How to Prepare for a Safety Inspection

Meet New FDA Commissioner Gottlieb

By Ann Meeker-O'Connell Found in: Article, Public Policy / Law, Regulatory Affairs

On May 9, 2017, the US Senate voted 57 to 42 to appoint Scott Gottlieb, MD, as the next Commissioner of the US FDA. The vote was…

Development of a Clinical Study Report

New EU Medical Devices & In Vitro Diagnostic Regulations

By Erik Vollebregt Found in: Article, Regulatory Affairs, Devices & Diagnostics

The EU Commission has just finalized the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The…

Biosimilar Development in Asia: Western Market Challenges

By Raymond A. Huml, MS, DVM, RAC; Oxana Iliach, PhD; Kamali Chance, MPH, PhD, RAC; Nigel R. Rulewski, MD Found in: Article, Biotechnology, Regulatory Affairs, R&D

There is a great interest from companies located in Asia to bring biosimilars into Western markets such as the United States…

New Drug Assessment Timelines in Brazil

By Jaime Oliveira, DIA Global Forum Central/South America Regional Editor Found in: Article, Regulatory Affairs, Public Policy / Law

As a mandatory gate to access markets and a highly visible stage of the process that medicines go through before being available…

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Boston Hotel

AVAREF Creating Better Regulatory Environment for Clinical Development in Africa

By Dr. David Mukanga, DIA Global Forum Africa Regional Editor Found in: Article, Regulatory Affairs, R&D

Several countries in Africa have unclear, confusing, and suboptimal regulatory processes for review and oversight of, as well as…

Scott Gottlieb

Meet New FDA Commissioner Gottlieb

By Ann Meeker-O'Connell Found in: Article, Public Policy / Law, Regulatory Affairs

On May 9, 2017, the US Senate voted 57 to 42 to appoint Scott Gottlieb, MD, as the next Commissioner of the US FDA. The vote was…

New EU Medical Devices & In Vitro Diagnostic Regulations

By Erik Vollebregt Found in: Article, Regulatory Affairs, Devices & Diagnostics

The EU Commission has just finalized the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The…

Biosimilar Development in Asia: Western Market Challenges

By Raymond A. Huml, MS, DVM, RAC; Oxana Iliach, PhD; Kamali Chance, MPH, PhD, RAC; Nigel R. Rulewski, MD Found in: Article, Biotechnology, Regulatory Affairs, R&D

There is a great interest from companies located in Asia to bring biosimilars into Western markets such as the United States…

New Drug Assessment Timelines in Brazil

By Jaime Oliveira, DIA Global Forum Central/South America Regional Editor Found in: Article, Regulatory Affairs, Public Policy / Law

As a mandatory gate to access markets and a highly visible stage of the process that medicines go through before being available…

AVAREF Creating Better Regulatory Environment for Clinical Development in Africa

By Dr. David Mukanga, DIA Global Forum Africa Regional Editor Found in: Article, Regulatory Affairs, R&D

Several countries in Africa have unclear, confusing, and suboptimal regulatory processes for review and oversight of, as well as…

FDA’s Expanded Access Program for Investigational Drugs

By Jonathan P. Jarow, MD; Peter Lurie, MD, MPH; Sarah Crowley Ikenberry, MA; Steven Lemery, MD, MHS Found in: Article, Regulatory Affairs

Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs...

Development of Biosimilars in Asia for Western Markets

By Raymond A. Huml, MS, DVM, RAC; Oxana Iliach, PhD; Kamali Chance, MPH, PhD, RAC; Nigel R. Rulewski, MD Found in: Article, Biotechnology, Regulatory Affairs, R&D

There is a great interest from companies located in Asia to bring biosimilars into Western markets such as the United States...

Assessing Decision-Making Quality in Medicines Development

By Magdalena Bujar, BSc, MSc; Ronan Donelan, MSc, PhD, FRSC; Neil McAuslane, MSc, PhD; Stuart Walker, PhD, MFPM, FIBiol, FRSC, FRCPath; Sam Salek, RPh, PhD, FFPM, MRPSGB, MCMS, FESCP Found in: Article, Clinical Research, Regulatory Affairs, Strategic Planning

Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery...

Ten-Year CDER Experience: Ensuring Patient Safety Part 2

By Jonathan P. Jarow, MD; Steven Lemery, MD, MHS; Kevin Bugin, MS, RAC; Naomi Lowy, MD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of...

Global Perspective: Compassionate Use & Expanded Access

By Tom Watson Found in: Article, Public Policy / Law, Regulatory Affairs, PE / Quality of life / Health

Whilst the complex ethical and benefit/risk questions that need to be considered when determining whether an investigational...

Preapproval Access and RTT: What Are We Willing to Give Up?

By Art Gertel, MS Found in: Article, Public Policy / Law, Regulatory Affairs, PE / Quality of life / Health

There is a growing concern within the US Food and Drug Administration (FDA) and the pharmaceutical/biotechnology communities...

Right to Try Law Provisions & Implications: Who Benefits?

By Lisa Kearns, MS, MA; Alison Bateman-House, PhD, MPH, MA Found in: Article, Regulatory Affairs, Public Policy, Health Care Compliance, Law, PE / Quality of life / Health

As of late November 2016, 32 states had adopted right to try laws. These laws are intended to allow terminally ill patients...

Reconciling State “Right to Try” Laws & FDA Expanded Access

By Robyn S. Shapiro, JD Found in: Article, Public Policy / Law, Regulatory Affairs, PE / Quality of life / Health

In the past few years, a number of states have passed “Right to Try” (RTT) laws. These laws aim to facilitate access by...

Accelerated Access to Medicines: An Ethical Analysis

By Jessica Pace, BSc, LLB(Hons), BPharm (Hons); Narcyz Ghinea, BSc(Hons); Ian Kerridge, BMed, BA, MPhil, FRACP, FRCPA; Wendy Lipworth, BSc(Med)(Hons), MBBS, MSc, PhD Found in: Article, PE / Quality of life / Health, Public Policy / Law, Regulatory Affairs

In recent years, a range of initiatives have been introduced to provide patients with access to medicines outside of...

8 Key Takeaways from the DIA Advertising and Promotion Regulatory Affairs Conference

By Raleigh E. Malik, PhD, DIA Senior Scientific Liaison Found in: Article, Advertising & Promotion, Marketing & Sales, Medical Communications, Regulatory Affairs

The DIA Advertising and Promotion Regulatory Affairs Conference brought together leaders from FDA, industry, and academia in…

Transitions, Introductions and a Notable Announcement

By J. Rick Turner, PhD Found in: Article, Clinical Research, Regulatory Affairs

It is a pleasure to write this Editorial as the Interim Editor-in-Chief of TIRS, and a privilege to shepherd the journal in the…

Managing Pharmacovigilance Outsourcing Partners

By Annette Williams Found in: Article, Outsourcing, Regulatory Affairs, Safety & Pharmacovigilance

Biopharmaceutical companies are facing increasing pressure to develop more robust pharmacovigilance programs, with teams...

Reference Safety Information in Clinical Trials: Increased EU Focus and Updated Guidance

By Esteban Herrero-Martinez, PhD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

Sponsors performing clinical trials in the EU must determine whether serious adverse reactions (SARs) to investigational...

Clinical Trials in India: Government Announces Beneficial Reforms

By Dr. Annappa Kamath Found in: Article, Clinical Research, Clinical Supplies, Regulatory Affairs

The regulatory environment in India for clinical trial conduct has been evolving since 2013, when the Indian Supreme Court...

Canada 2017: Celebrating Our Sesquicentennial & 2016 Achievements

By Kimby Barton Found in: Article, Regulatory Affairs

In October 2016, after intensive negotiations, Canada signed a historic trade agreement with the European Union: the Canada...

Pharmacovigilance Programme of India: SWOT Analysis

By Dr J. Vijay Venkatraman Found in: Article, Safety & Pharmacovigilance, Regulatory Affairs

In recent years, pharmacovigilance (PV) has become a high priority, growing public health concern worldwide. India, for its...

ICH/DIA Joint Tokyo Workshop after ICH Japan Meeting

By Junichi Nishino Found in: Article, Regulatory Affairs, Clinical Research

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has now reached...

Africa: Accelerating Access to Vaccines & Medicines

By Dr. Vincent Ahonkhai Found in: Article, Regulatory Affairs

The African Vaccines Regulatory Forum (AVAREF) initiative is developing proposals to streamline and lend transparency to the...

Brexit Implications: Pharmacovigilance in UK & Europe

By Dr. David Jefferys Found in: Article, Safety & Pharmacovigilance, Regulatory Affairs

The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the...

Pharmacovigilance Programme of India: SWOT Analysis

By Dr J. Vijay Venkatraman Found in: Article, Safety & Pharmacovigilance, Regulatory Affairs

In recent years, pharmacovigilance (PV) has become a high priority, growing public health concern worldwide. India, for...

Vaccine Policy Reform in Japan: Progress & Challenges

By Yoshikata Furuya Found in: Article, Safety & Pharmacovigilance, Public Policy / Law, Regulatory Affairs

It is said that there is a “vaccine gap” between Japan and other developed countries. Indeed, the number of available...

Ringing in the New: 2017 FDA Rules and Guidance

By Ann Meeker-O’Connell Found in: Article, Regulatory Affairs

As 2016 came to a close, the US FDA issued or signaled intent to issue updated regulations and final guidance that impact...

iPLEDGE: Patient Access in Restrictive RMPs

By Kirk W. Kerr, PhD; Marta E. Wosinska, PhD Found in: Article, Safety & Pharmacovigilance, PE / Quality of life / Health, Regulatory Affairs

The isotretinoin risk management program iPLEDGE places requirements on patients and providers to ensure that the benefits...

Saudi Arabian Patient Evaluation of Package Leaflets

By Sinaa Alaqeel, MSc, PhD; Nahed Al Obaidi, MSc Found in: Article, Medical Communications, PE / Quality of life / Health, Regulatory Affairs

The purpose of this study was to determine how well patients could correctly recognize and comprehend the various information...

FDA’s Expedited Programs: Impact on New Therapies

By Nehar Damle, PharmD(cand); Shilvi Shah, PharmD(cand); Praneeta Nagraj, PharmD; Pardis Tabrizi, PharmD; Gustavo Enrique Rodriguez, PharmD; Rahul Bhambri, PharmD Found in: Article, Regulatory Affairs

The US Food and Drug Administration’s (FDA’s) Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy...

Sakigake, PRIME and Breakthrough Therapy Designation

By Hideyuki Kondo, MBA; Toshiyuki Hata, PhD; Konomi Ito, BSc; Hisashi Koike, PhD; Noriatsu Kono, MSc Found in: Article, Regulatory Affairs

Following the Breakthrough Therapy Designation system in 2012 in the United States, the Sakigake Designation was introduced...

Update on Registration of Biosimilars in Malaysia

By Yvonne Siew; Khoon Khoo, BPharm(Hons), MMedSc, PhD(Pharm); Tien Yew Tang, BPharm(Hons); Pick Sim Goh, BPharm(Hons); Hazureen Mohd Halimi, BPharm(Hons); Azizah Ab Ghani, BPharm(Hons), MPharm, PhD(Pharm) Found in: Article, Regulatory Affairs, Biotechnology

Because of its structure and complex manufacturing process, every biotherapeutic product (BTP; medicinal products made by...

FDA-Approved Fixed-Dose Combination Products 2010-‘15

By Kyu Chan Kwon, MS; Chulung Lee, PhD Found in: Article, Regulatory Affairs

Fixed-dose combination (FDC) drugs have been an attractive product in pharmaceutical markets because of their unique advantages...

Social Media Monitoring and Adverse Drug Reactions

By Marina Lengsavath, MSc; Anne Dal Pra, PharmD; Anne-Marie de Ferran, PharmD; Sabine Brosch, MPharm, RN; Dr. Linda Härmark, PharmD, PhD; Victoria Newbould, MSc; Susana Goncalves, PharmD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

In the context of the European Union’s Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug...

ICH Culture: Its Maintenance and Development

By Hironobu Saito, PhD; Masafumi Yokota, DVM, PhD; Akira Kawahara, PhD; Tatsuo Kurokawa, PhD Found in: Article, Regulatory Affairs

The founding industry members (European Federation of Pharmaceutical Industries and Associations [EFPIA], Japanese...

2017 Ushers in New FDA Rules and Guidance

By Ann Meeker-O’Connell Found in: Article, Regulatory Affairs

As 2016 came to a close, the US FDA issued or signaled intent to issue updated regulations and final guidance that impact…

Falsified Medicines: EU Fighting Global Problem

By Lynda Wight Found in: Article, Regulatory Affairs, Quality Assurance, Quality Control, Quality Assurance, Quality Control

The Falsified Medicines Directive (2011/62/EU) hugely impacts the current supply chain. The Delegated Act on Safety Features...

Australia: Accelerated Reviews & Adaptive Licensing

By Richard Day, AM, MD, FRACP Found in: Article, Regulatory Affairs

Dr. John Skerritt is Deputy Secretary of the Australian Department of Health and is responsible for the Australian Regulator...

Bringing the EU to Japan

By Masayoshi Higuchi, Akiko Ikeda, Junichi Nishino Found in: Article, Regulatory Affairs

The 3rd DIA EMA Training Course in Japan, held in September 2016, welcomed 20 participants from industry and the PMDA...

China 2016: Regulatory Reform Year One

By Ling Su, PhD Found in: Article, Regulatory Affairs, Good Clinical Practices & QA, Public Policy / Law

We now come to the end of 2016, a year that many people familiar with the Chinese drug regulatory scene would call “China...

Capacity Building: Stronger ASEAN Regulatory Systems

By Hozanna Ngoh; Silke Vogel, PhD Found in: Article, Regulatory Affairs

An aging global population, increasing threats of emerging diseases, and the expanding repertoire of innovative health care...

Regulatory Science for Patient-Engaged Treatment

By Atsushi Tsukamoto, PhD Found in: Article, PE / Quality of life / Health, Regulatory Affairs

Incorporating advanced technologies and knowledge in drug development processes is becoming more and more important to...

How PDUFA Aligns Clinical & Regulatory Science

By Chris Slawecki Found in: Article, Regulatory Affairs, Clinical Research, PE / Quality of life / Health, R&D

Enacted in 1992 and renewed every subsequent five years, PDUFA authorizes FDA to collect user fees from companies that produce…

Developments in Transparency in Europe

By John Lisman Found in: Article, Regulatory Affairs

In October 2016, the European Medicines Agency (EMA) started publishing clinical data submitted by pharmaceutical companies...

Benefit-Risk Assessments in Marketing Applications

By JuAn Wang, MD; Anne Wolka, RPh, PhD; Kristin Bullok, PhD; Greg Anglin, PhD; Christine Radawski, MPH; Rebecca Noel, DrPH Found in: Article, Regulatory Affairs

A recent publication from Eli Lilly and Company provided guidance on incorporation of a structured benefit-risk assessment...

Regulatory Science to Advance Regenerative Medicine

By Christopher-Paul Milne, DVM, MPH, JD; James Mittra, PhD; Naoko Kojima, MPS; Daisuke Sugiyama, MD, PhD; Josephine Awatin, BS; Gabrielle Simmons Found in: Article, Regulatory Affairs

Regenerative medicine (RM) is a game-changing technology with the potential to repair damaged tissues and organs, but its...

Bayesian Method for Blinded Data Safety Monitoring

By Patrick M. Schnell, BS; Greg Ball, PhD Found in: Article, Regulatory Affairs

The FDA safety reporting Final Rule requires an expedited safety report whenever aggregate analysis indicates a clinically...

CDRH Adaptive Design Practice: Jan 2007 – May 2013

By Xiting Yang, PhD; Laura Thompson, PhD; Jianxiong Chu, PhD; Sherry Liu, MS; Hong Lu, PhD; Jie Zhou, PhD; Shanti Gomatam, PhD; Rong Tang, PhD; Yu Zhao, PhD; Yunjiang Ge, MS; Gerry W. Gray, PhD Found in: Article, Regulatory Affairs

Adaptive designs have generated great interest in the clinical trial community as a result of their versatility and efficiency...

New Drug Applications Regulatory Timing & Outcomes

By Petra Dörr, PhD; Alison Wadworth, BPharm; Tina Wang, BSc, MSc; Neil McAuslane, MSc, PhD; Lawrence Liberti, MSc, RPh, RAC Found in: Article, Regulatory Affairs

This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to...

A Toolkit for the Management of Protocol Deviations

By Sandy Mohan, PhD; Munish Mehra, MSc, PhD; Maryrose Petrizzo, MS; Terry Katz, MS, CQE, PSTAT Found in: Article, Regulatory Affairs

The DIA’s Good Clinical Practice and Quality Assurance Community (DIA GCP/QA) created a working group to develop templates for...

Registration Procedure Impact on Off-Label Usage?

By Ian Ellul, BPharm(Hons), PhD; Victor Grech, MD, PhD, FRCP(C)H, MRCP, DCH, CLJ; Simon Attard-Montalto, MBChB, MD, FRCP, FRCP(C)H, DCH Found in: Article, Regulatory Affairs

In Malta, off-label prescribing of medicines in children stands at 45%, mainly because of failure by prescribers to follow the...

CDER Formal Dispute Resolution Analysis 2003 – 2014

By Khushboo Sharma, MBA; Afi Harrington, MOR, PhD; Sallamar Worrell, Amy Bertha Found in: Article, Regulatory Affairs

Scientific and/or medical disputes will inevitably arise with regard to the US Food and Drug Administration’s (FDA’s) decision...

CDER Experience: Investigative Drug Expanded Access

By Jonathan P. Jarow, MD; Steven Lemery, MD, MHS; Kevin Bugin, MS, RAC; Sean Khozin, MD, MPH; Richard Moscicki, MD Found in: Article, Regulatory Affairs

The purpose of this study was to describe the experience of the Center of Drug Evaluation and Research (CDER) with expanded...

Japan Drug Use: Clinical vs. Regulatory Practice

By Nanae Tanemura, PhD; Yoshiaki Uyama, PhD; Kengo Nagashima, PhD; Takahiro Suzuki, MD, PhD; Yasuko Asahina, PhD; Yoshio Kobayashi, MD, PhD; Masaomi Iyo, MD, PhD; Koutaro Yokote, MD, PhD; Hideki Hanaoka, MD, PhD Found in: Article, Clinical Research, Regulatory Affairs

In this study, differences in older patients between drug use as reported in clinical practice and in clinical trials for...

East Africa Joint Regulatory Assessment Initiatives

By Vincent Ahonkhai, MD Found in: Article, Regulatory Affairs

The African Medicines Regulatory Harmonization initiative has highlighted several of their recent activities including the...

EU-US Collaboration to Boost Medicine Development for Rare Diseases

Found in: Article, Rare, Orphan Diseases, Regulatory Affairs, Clinical Research

The European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) have set up a new “cluster” on rare diseases to…

When Should Foreign Sponsors Appoint Their ICR in Japan?

By Shogo Nakamori Found in: Article, Good Clinical Practices & QA, Regulatory Affairs

The proportion of multinational clinical trials that include Japan has grown from 7.4% in 2007 to 28.1% in 2013, and the Japan…

How Far Can Regulators Drive Patient Engagement?

Found in: Article, Clinical Research, Comparative Effectiveness, PE / Quality of life / Health, Regulatory Affairs

Patient engagement is a full-fledged global movement driven not only by patients but by agencies such as the US FDA and the UK…

FDA Commissioner Califf Speaks with "Global Forum"

By Alberto Grignolo, PhD, Global Forum Deputy Editor Found in: Article, PE / Quality of life / Health, Comparative Effectiveness, Clinical Research, Regulatory Affairs

After appearing in the DIA 2016 Annual Meeting panel discussion International Regulatory...

FDA Is Reaching Out to You on Social Media!

By Ginneh D. Stowe, MS, CDER, FDA Found in: Article, PE / Quality of life / Health, Regulatory Affairs, Medical Communications

A key element of US FDA’s mission is helping the American public get the accurate, science-based medical product information they…

The Evolution of Patient Engagement at FDA

By John Whyte, MD, Director, CDER’s Professional Affairs & Stakeholder Engagement Staff Found in: Article, PE / Quality of life / Health, Regulatory Affairs

The drug approval process has traditionally relied heavily on scientific evidence for safety and efficacy. In a recent evolution…

Breaking News: New Breakthrough Pathways

Found in: Article, Regulatory Affairs, R&D, Rare, Orphan Diseases, Clinical Research

Patient advocacy, unmet medical needs and regulatory innovations are driving accelerated review and approvals of critical…

FDA Accelerated Pathways: The New Normal

By Barry Farrimond, Jonathan Fleming and Mark Mathieu Found in: Article, Regulatory Affairs, Clinical Research, Rare, Orphan Diseases

The FDA’s accelerated pathways (APs) – including Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), Fast Track…

Future Vision: Big Data in Regulatory Environment

By Richard C. Zink, PhD Found in: Regulatory Affairs, Comparative Effectiveness, Clinical Data Management, Good Clinical Practices & QA, Rare, Orphan Diseases, Article

The forward-looking DIA 2016 Annual Meeting session Envision the Future: How Big Data & Artificial Intelligence Change our…

Regulators Discuss BREXIT & Cancer Moonshot

Found in: Article, Regulatory Affairs, GMP, Public Policy / Law, Safety & Pharmacovigilance, Strategic Planning

One of the first DIA 2016 Annual Meeting DIAmond sessions, International Regulatory Convergence, Collaboration, and Cooperation…

Elevate Patient Voice to Advance Drug Development

By Ann Meeker-O'Connell, DIA Global Forum US Regional Editor Found in: Article, Regulatory Affairs, Clinical Research, Patient Engagement

The development of the US FDA’s Patient-Focused Drug Development (PFDD) initiative in 2012 heralded a new era of patient…

FDA QS Implementation for CoDx Lab-Developed Tests

By Joshua D. Levin, Kennita N. Riddick and Eunice Y. Lee Found in: Article, Regulatory Affairs, GLP, Quality Assurance, Quality Control, Devices & Diagnostics

FDA’s guidance document for in vitro companion diagnostic devices (IVD CoDx) states that, ideally, an IVD CoDx is approved at…

RbM: Hype, Paradigm Change or New Frontier?

By Dr. Peter Schiemann Found in: Article, Regulatory Affairs, Clinical Research, Good Clinical Practices & QA, Project Management

Since FDA and EMA published their guidance and reflection paper on risk-based monitoring (RbM) and oversight in clinical trials…

What IS a Combination Product?

Found in: Article, Combination Products, Regulatory Affairs

A combination product is comprised of two or more regulated components – i.e.,..

Editorial: Progress on Behalf of Children

By Stephen P. Spielberg, MD, PhD; Editor-in-Chief, DIA Publications Found in: Article, Clinical Research, Regulatory Affairs

In July 2000, our working on group on ICH E-11 completed its task of writing a document designed to harmonize...

FDA Commissioner Speaks with "Global Forum"

By Dr. Alberto Grignolo, PAREXEL; Deputy Editor, Global Forum Found in: Article, Comparative Effectiveness, Patient Engagement, Regulatory Affairs

After appearing in the DIA 2016 Annual Meeting panel discussion "International Regulatory Convergence, Collaboration and...

The Evolution of Patient Engagement at FDA

By John Whyte, MD Found in: Article, PE / Quality of life / Health, Patient Engagement, Regulatory Affairs, R&D

The drug approval process has traditionally relied heavily on scientific evidence for safety and efficacy. In a recent evolution...

FDA’s Accelerated Pathways Are The New Normal (And They Work if You Work Them)

By Barry Farrimond, Jonathan Fleming and Mark Mathieu Found in: Article, Public Policy, Health Care Compliance, Law, Public Policy / Law, Regulatory Affairs, R&D, Submissions

The FDA’s accelerated pathways (APs) – including Accelerated Approval (AA), Breakthrough Therapy Designation (BTD)...

An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

By Stephanie Krumholz-Bahner, Dr rer medic, NDA Regulatory Service Switzerland GmbH, Switzerland; Mimmo Garibbo, Ethical GmbH, Switzerland; Kenneth A. Getz, MBA, Tufts University; Beat E. Widler, PhD, Widler & Schiemann Ltd, Switzerland Found in: Article, Clinical Research, Regulatory Affairs, Study Endpoints

Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants…

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

By Mark Geanacopoulos, PhD; Ruth Barratt, PhD, DVM; CDER, Office of Translational Sciences Found in: Article, Regulatory Affairs, Statistics

Since 2008, the Critical Path Initiative has supported FDA’s program of intramural research projects in regulatory science, with…

Breakthrough Therapy Designation Bringing Innovation Swiftly to Patients

By Arpita Shah, PharmD, RPh; Regulatory Affairs, Celgene Corporation Found in: Article, Clinical Research, Public Policy / Law, Public Policy, Health Care Compliance, Law, R&D, Regulatory Affairs

In early 2012, the Breakthrough Therapy Act was introduced into the US House of Representatives and the Senate...

Clinical Data Transparency

By Janet Woodcock, MD and Anne M. Rowzee, PhD Found in: Clinical Data Management / eClinical, Public Policy / Law, Regulatory Affairs, Clinical Research, Article

It’s no surprise that DIA thought leaders have named “Clinical trial data transparency/data sharing” as the #2 trend to shape the world of medical product development in 2015.

Global Forum Special Section: Regulatory Collaboration: The First APEC RHSC MRCT Pilot Training Program

By Capt. Justina A. Molzon, MS Pharm, JD Found in: Article, Regulatory Affairs

The world’s first pilot training program on Multi-Regional Clinical Trials (MRCTs), endorsed by APEC (Asia-Pacific Economic Cooperation) and organized by Singapore’s Health Sciences Authority (HSA) and the Duke- NUS Graduate Medical School Singapore (Duke-NUS), was successfully concluded in Singapore this past March.

Global Forum Special Section: The DUKE-National University of Singapore (NUS) TeamLEAD Approach to Learning

By Silke Vogel, PhD Found in: Article, Regulatory Affairs

From March 17-19, 2014, nearly 50 mid- to senior-level MRCT evaluators and regulators from 19 APEC countries gathered in Singapore to attend the Pilot Workshop of the APEC Regulatory Science Center of Excellence (COE).

Global Forum Special Section: Regulatory Collaboration in Asia Pacific Economies

By Capt. Justina A. Molzon, MS Pharm, JD Found in: Article, Regulatory Affairs

The Asia-Pacific Economic Cooperation (APEC) is a forum for Pacific Rim economies to promote economic cooperation throughout the Asia Pacific region.

Global Forum Special Section: What Happened in Singapore Should Not Stay in Singapore

By Bob Li Found in: Article, Regulatory Affairs

A pilot course over three days delivered by six faculty members was conducted at the Duke-NUS CoE for MRCT Methodology March 17-19, 2014.

Global Forum Special Section: Q&A with Gayatri Rao, Director, OOPD

By Gayatri R. Rao, MD, JD Found in: Regulatory Affairs, Article, Clinical Research, Anti-doping, Rare, Orphan Diseases

Gayatri R. Rao, MD, JD, serves as Director for the Office of Orphan Products Development (OOPD) at FDA.

How to Prepare for a Safety Inspection

Development of a Clinical Study Report

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Boston Hotel

Clinical Statistics for Nonstatisticians

Sheraton Boston Hotel

New Drug Product Development and Life Cycle Management

Sheraton Boston Hotel

Clinical Trial Disclosure and Data Transparency Conference

Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

DIA Global Center

Clinical Project Management

DIA Global Center

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Philadelphia University City

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Sheraton Philadelphia University City

Biosimilars Conference

Hyatt Regency Bethesda

DIA Oligonucleotide-Based Therapeutics Conference

Bethesda North Marriott Hotel and Conference Center

Combination Products Conference

Marriott Bethesda North Hotel

Basics of the NDA Phase

Adaptive Design in Clinical Trials: When and How to Apply

DIA Global Center

Pharmacovigilance and Risk Management Strategies Conference

Omni Shoreham Hotel

Regulatory Submissions, Information, and Document Management Forum

Bethesda North Marriott Hotel and Conference Center