ARTICLES BY MARK DURIVAGE

• Circumstances For Delaying, Denying, Limiting, Or Refusing An FDA Inspection

  3/1/2023

  Delaying, denying, limiting, or refusing a drug or device inspection without a reasonable justification will result in a less than collegial atmosphere during an FDA inspection.

• FDA Seeks Comment On Conducting Remote Regulatory Assessments

  8/11/2022

  The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

• FDA Seeks Comment On ICH Q9(R1) Quality Risk Management

  7/5/2022

  ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

• FDA Publishes Guidance For Biopharma Container Labels & Carton Labeling Design

  6/13/2022

  The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

• The Voluntary Improvement Program: FDA Seeks Public Comment On Draft Guidance

  6/6/2022

  The FDA seeks comments on its proposed guidance describing its policy regarding FDA's participation in the Voluntary Improvement Program. The program is facilitated by the Medical Device Innovation Consortium. Comments are due by July 5, 2022.

• FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance

  5/24/2022

  The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.

• FDA Issues Guidance On Initiation Of Voluntary Recalls

  4/5/2022

  This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

• FDA Seeks Public Comment On Quality Metrics Reporting Program

  3/17/2022

  The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

• FDA Issues Proposal To Amend The Medical Device Quality System Regulation

  2/24/2022

  The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016. The proposed amendment will also affect 21 CFR Part 4: Regulation of Combination Products.

• FDA Releases CMC Postapproval Manufacturing Changes For Specified Biological Products To Be Documented In Annual Reports

  2/18/2022

  New CDER guidance represents the FDA's thinking regarding the changes that BLA holders for specified biological products must document in an annual report. The products include therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, mAb products for in vivo use, and therapeutic recombinant DNA-derived products.

• Clinical Trials: FDA Proposes Benefit-Risk Assessment For New Drug And Biological Products

  2/11/2022

  The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions. Communication between the sponsor and the FDA regarding the benefit-risk assessment is typically conducted at the end of the Phase 2 study, which can help influence the design of Phase 3 studies.

• EMA Publishes Guideline On Quality Documentation For Medicinal Products

  8/2/2021

  This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.

• With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices

  1/25/2021

  The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?

• Remote Auditing Best Practices For GMP Compliance

  3/25/2020

  Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

• FDA Updates Several 510(k) Guidance Documents

  10/21/2019

  The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.