Navigating the Medical Device User Fee Act (MDUFA)
By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA -
Published 25 May 2017
This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.
Categories: Features, US, CDRH, Medical Devices, Submission and registration
Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees
Challenges Providing Pharmaceutical Products to Syrian Refugees
By Zeina Sahloul -
Published 24 May 2017
This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.
Categories: Features, Middle East, WHO, Crisis management, Drugs, Submission and registration
Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF
ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry
By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer -
Published 16 May 2017
This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.
Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality
Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD
Generic Drug User Fee Act (GDUFA): Overview and Proposed Changes for 2018
By Karla Mark-Lantz, PhD -
Published 11 May 2017
This article discusses aspects of the Generic Drug User Fee Act enacted by Congress as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), including fees, changes enabling FDA to speed up reviews, GDUFA goals and proposed changes and impacts as the first five–year phase concludes in 2017.
Categories: Features, US, FDA, Generic drugs, Submission and registration
Regulatory Harmonization Initiatives
By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC -
Published 09 May 2017
This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.
Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices
Thailand's Approach to Drug Quality Assurance: Creation of the Green Book
By Thanita Patthamajinda, RPh -
Published 27 April 2017
This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.
Categories: Features, Asia, Drugs, Quality
Tags: Thailand, Green Book, Quality Assurance
Identification of Medicinal Products (IDMP) Standards Part 3: Steps to Prepare for IDMP Implementation
By Dieter Schlaps -
Published 26 April 2017
This article discusses the gap analysis and preliminary activities necessary to prepare a pharmaceutical company for the upcoming IDMP standards; it is the final article in a three part series on the standards and their respective implementation guidelines. The first two articles presented reasons for the new standard, the driving forces behind IDMP, and the concepts behind the standard as well as the current timelines for introducing IDMP in worldwide markets.
Categories: Features, EMA, FDA, ISO, Drugs
Impact of the Revised EU Clinical Trial Regulation
By Siegfried Schmitt, Federico Bonacci, MD, Daniela Lisini, PhD, Dr. Viviana Mascilongo -
Published 24 April 2017
Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.
Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs
Tags: Clinical Trial Regulation, EU No 536/2014
Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products
By Robert D. Cumming, Nancy W. Mathewson, Esq -
Published 14 April 2017
This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.
Categories: Features, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices
Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA
Strategies Adopted by Innovator Companies in Response to Biosimilars Competition
By Charu Manaktala, MD, MBBS, Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD -
Published 10 April 2017
This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.
Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration
Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension
Biosimilar Intellectual Property Issues in the US: An Update
By Raymond A. Huml, MS, DVM, RAC, Allen R. Baum, JD, Jill Dawson, PhD -
Published 07 April 2017
This article provides an update on US biosimilar intellectual property issues in areas including the complex and evolving areas of patent protection, market exclusivity, the 'patent dance,' and lifecycle planning.
Categories: Features, US, FDA, Biologics and biotechnology, Submission and registration
Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April
By Gloria Hall -
Published 05 April 2017
The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April.
Categories: Features, Asia, Europe, Oceania, US, EC, FDA, Business Skills, Human cell and tissue, Medical Devices
Tags: Features, Regulatory Focus
EU and US Regulations for Chemical Components in Medical Devices
By Kenneth Stanvick -
Published 31 March 2017
This article discusses a number of regulations directed at the use of chemical components in medical devices, both in the EU and US. The author reviews legislation, offers compliance advice and warns about the penalties of noncompliance.
Categories: Features, Europe, US, EC, FDA, Compliance, Medical Devices
Tags: Chemical Components, Restricted Substances
Drug Regulatory Authority of Pakistan: Organizational Structure, Functions and Future Challenges
By Shahid Hussain, RPh, PharmD -
Published 30 March 2017
This article discusses the development of a more effective pharmaceutical regulatory environment in Pakistan through the establishment of a regulatory agency designed to address current good manufacturing practices and quality management systems for drug production to improve the availability, accessibility and affordability of drugs.
Categories: Features, Compliance, Drugs, Quality, Submission and registration
Tags: DRAP, Drug Regulatory Authority of Pakistan
Is the Current Regulation of Autologous Stem Cells Appropriate?
By Dr. Ian Prosser -
Published 29 March 2017
This article discusses the regulation of autologous stem cells and tissue therapies in Australia by addressing issues such as the safety and efficacy of cell therapies, which therapies are regulated, what regulators are doing in other countries and "next steps" in cell and tissue regulation.
Categories: Features, Japan, Europe, Oceania, US, EMA, FDA, MHLW, PMDA, TGA, Human cell and tissue
Tags: Autologous Stem Cells
Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan
By Satoshi Koike, PhD, DSc -
Published 23 March 2017
This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.
Categories: Features, Japan, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Submission and registration
Tags: Common Technical Document, CTD
Fast Facts: Serious Adverse Event Reporting Requirements in the US
By Valerie Fauvelle, MS, RAC -
Published 22 March 2017
This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.
Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance
Tags: Adverse Event Reporting
When to Submit a 510(k) (Devices and Software): A Regulatory Perspective
By Jeff Ryberg -
Published 21 March 2017
This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.
Categories: Features, US, FDA, Medical Devices, Submission and registration
Tags: 510(k), Software
The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues
By Mary Ellen Cosenza, PhD, RAC -
Published 16 March 2017
This article discusses why regulatory and business functions need to work together to ensure success in label development, launch, promotion and lifecycle management strategy and regulatory intelligence and provides successful partnership examples.
Categories: Features, Business Skills, Communication
Strategies and Tactics to Successfully Outsource Regulatory Work
By Bill Snyder -
Published 15 March 2017
This article highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work. The author Includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing.
Categories: Features, US, Business Skills
Tags: Outsourcing, Performance Metrics
2017 Regulatory Intelligence Tools Update: Drugs
By Meredith Brown-Tuttle, RAC, FRAPS, Linda Bowen, MS, RAC, FRAPS -
Published 09 March 2017
When tasked with something new or different in regulatory, sometimes the hardest challenge is knowing where to find the information. This article provides an abundance of tools, links and places to start your journey of regulatory information discovery.
Categories: Features, Biologics and biotechnology, Drugs, Regulatory intelligence
Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March
By Gloria Hall -
Published 08 March 2017
The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in March.
Categories: Features, CFDA, EMA, FDA, Health Canada, ISO, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy
Tags: Regulatory Focus, Feature Articles, Feature Summary
MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU
By Rod Ruston -
Published 03 March 2017
This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.
Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration
Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR
Advanced Therapy Medicinal Products: An Evolving Regulatory Landscape
By Patricia Hurley, PhD, Sarah Jurmeister, PhD, Kathryn Parsley, PhD -
Published 28 February 2017
This article was developed from a presentation at RAPS Regulatory Convergence in September 2016 in San Jose, California, US. It was the opening presentation in the "Global Developments in Cell and Gene Therapy" session and covered introductory Advanced Therapy Medicinal Product (ATMP) concepts from definitions to strategic considerations and challenges currently faced by developers in this field.
Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory strategy
Tags: Advanced Therapies, ATMP
Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap
By Dieter Schlaps -
Published 28 February 2017
This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard.
Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs
Tags: ISO, ISO IDMP, Identification of Medicinal Products