Regulatory Oversight and Compliance

March 02, 2022

Califf will face challenges that include COVID-19, opioids, and user fees.

March 02, 2022

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

March 01, 2022

FDA has revised the Emergency Use Authorization for sotrovimab.

February 28, 2022

EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.

February 28, 2022

EMA has recommended approval of Spikevax for children aged 6 to 11.

February 28, 2022

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

February 25, 2022

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.

February 24, 2022

FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.

February 24, 2022

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

February 24, 2022

USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.