Regulatory Oversight and Compliance

MHRA Approves COVID-19 Antiviral Drug

November 05, 2021

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

Eli Lilly Withdraws COVID-19 Treatments from EMA Review

November 04, 2021

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

Will Pharma Accept the Democrats’ Drug Pricing Deal or Continue to Fight Reform?

November 03, 2021

Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.

Novavax COVID-19 Vaccine Receives EUA in Indonesia

November 03, 2021

Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.

GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 Pandemic

November 02, 2021

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

Detecting and Determining Quantitation Limits for Impurities

November 02, 2021

Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.

FDA Approves Novartis’ Scemblix for Treatment of Chronic Myeloid Leukemia

November 02, 2021

Novartis’ scemblix (asciminib) is designed to provide a single treatment option to patients struggling with chronic myeloid leukemia.

Pandemic Alters FDA Inspections and Quality Oversight

November 02, 2021

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

The Remote Audit–A Tongue-in-Cheek Memo

November 02, 2021

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.

FDA Approves AbbVie’s Vuity for Presbyopia Treatment

November 01, 2021

Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.