ARTICLES BY MARK DURIVAGE

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

  1/9/2023

  The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

• 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 Updates Guidance For Investigating OOS Test Results for Pharma Production

  6/24/2022

  FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.

• FDA Proposes Benefit-Risk Considerations For Product Quality Assessments

  6/20/2022

  The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.

• 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.

• 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 Proposes Updated Guidance On Verification Systems Under The DSCSA For Certain Prescription Drugs

  4/19/2022

  The FDA is soliciting comments on its proposed update to its "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs" guidance. When a trading partner suspects counterfeit or fraudulent products, or receives a request for verification from the FDA, partners are required to quarantine the product and to investigate its legitimacy. 

• 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 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.

• FDA Proposes Inspection Of Injectable Products For Visible Particulates

  2/1/2022

  FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.

• 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.

• FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices

  7/26/2021

  On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.