Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 9 plications. Some noteworthy guidance documents include the following: • Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry • Considerations for the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry • Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Therapies; Draft Guidance for Industry. COVID-19 guidance The first quarter of 2021 saw the agency publish guidance on a variety of subjects, with treatments and products to address COVID-19 receiving a good deal of the agency's attention. In March 2021, FDA published guidance providing recommendations for reporting and implementing changes to COVID-19 container closure system (CCS) components that con- sist of glass vials and stoppers for parenteral sterile drug products and biologics (4). The guidance dis- cusses regulatory approaches to CMC changes and common changes to glass vials and stoppers. The guidance also discusses risk-based tools for imple- menting CCS changes and comparability protocols. FDA announced on Feb. 22, 2021 that it issued a suite of guidance documents to address the emer- gence of variants of SARS-CoV-2. The guidance documents include an update to the October 2020 guidance on Emergency Use Authorization (EUA) for vaccines to prevent COVID-19, guidance on the impact of the variants on monoclonal antibody (mAb) products and other treatments, and a guidance the impact of the variants on COVID-19 tests (5). The updated guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, offers recommenda- tions to vaccine developers regarding virus variants, including developers who already received EUA for their vaccine. The agency stated, in a press release, that FDA-authorized vaccines are effective against the cur- rent strains of SARS-CoV-2, but it may be necessary to tailor vaccines should a new variant emerge in the United States that is "moderately or fully resistant to the antibody response elicited by the current genera- tion of COVID-19 vaccines." On Feb. 11, 2021, FDA published guidance that gives recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma (6). Recommendations are also provided regarding blood collection. The document also discusses the agency's interim compliance and enforcement policy for in- vestigational new drug requirements for the use of investigational convalescent plasma. The new guid- ance, which supersedes guidance issued in January 2021 and previous versions, includes revised recom- mendations for convalescent plasma donors. "The re- visions address when individuals who have received an investigational COVID-19 monoclonal antibody therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal an- tibody therapy, qualify as convalescent plasma donors," the guidance states. References 1. J. Wechsler, PharmTech 45 (3) 2021. 2. CDER, CDER Guidance Agenda New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 (Janu- ary 2021). 3. CBER, Guidance Agenda: Guidance Documents CBER is Plan- ning to Publish During Calendar Year 2021. 4. FDA, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers, Guidance for Industry (CBER, CDER, March 2021). 5. FDA, "Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants," Press Release, Feb. 22, 2021. 6. FDA, Investigational COVID-19 Convalescent Plasma, Guidance for Industry (CBER, Feb. 11, 2021). PT

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