Regulatory/GMP Compliance

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

Industry representatives sound off on FDA’s FARS report, released in January this year.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

Public health challenges have highlighted the need for agility in maintaining the quality of medicines.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.