Regulatory Oversight and Compliance

EMA and HMA Publish Joint Strategy for Medicines Regulation to 2025

December 11, 2020

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

EMA Launches Investigation into Cyberattack

December 10, 2020

The European Medicines Agency has launched a full investigation into a cyberattack.

FDA Posts Briefing Documents for Vaccine Committee Meeting

December 08, 2020

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

Regenecare HA Hydrogel Recalled

December 08, 2020

The product is being recalled because of Burkholderia cepecia contamination.

FDA Publishes Best Practices for Developing Proprietary Names for Drugs

December 08, 2020

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

Combination Product Guidance Issued by FDA

December 08, 2020

The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.

J&J Initiates COVID-19 Vaccine Approvals in Canada and Europe

December 03, 2020

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

Can Pharma Quality Go High Tech?

December 03, 2020

The COVID-19 pandemic has pushed more pharmaceutical companies and regulators to use new technologies for remote quality audits and inspections.

Nitrosamine Impurities in Medicinal Products

December 03, 2020

Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

USP, COVID-19, and Plans for the Future

December 03, 2020

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.