Regulatory Oversight and Compliance

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.

The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.

The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

The Committee for Medicinal Products for Human Use of the European Medicines Agency presented a positive opinion of bluebird bio’s SKYSONA (elivaldogene autotemcel, Lenti-D), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy, an X-linked metabolic disorder.

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.

The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.

Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

FDA has approved AstraZeneca’s Farxiga (dapagliflozin) for treating chronic kidney disease in the United States.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

The UK’s Medicines and Healthcare products Regulatory Agency has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.

The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.