Regulatory Oversight and Compliance

FDA Weighs in on Remote Inspections

April 16, 2021

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

EC Approves BMS’ Opdivo in Combination with Cabometyx for Advanced RCC

April 16, 2021

BMS has announced that the EC has approved Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.

Safety Review of Janssen COVID-19 Vaccine Continues in Europe

April 16, 2021

EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.

Further Context on AstraZeneca COVID-19 Vaccine Risks to be Provided by EMA

April 16, 2021

EMA is continuing to monitor the incidences of very rare blood clots with low blood platelets occurring after vaccination with the AstraZeneca COVID-19 vaccine (Vaxzevria).

EMA Review of VIR-7831 for COVID-19 Underway

April 16, 2021

EMA has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.

MHRA and EC Grant Marketing Authorization for Biogen’s MS Treatment

April 16, 2021

Biogen UK has announced that the UK’s MHRA and the EC have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).

FDA Lifts Restrictions on Access to Abortion Pill

April 16, 2021

Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

April 14, 2021

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

FDA Inspections During COVID-19: A Brave New World

April 14, 2021

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

Cavazzoni Named CDER Director

April 13, 2021

Acting FDA commissioner announces permanent appointment of Patrizia Cavazzoni as CDER director, following year-long acting-director role.