Quality Systems

Articles

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences. 

EMA’s CHMP Starts Rolling Review of Inactivated COVID-19 Vaccine

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

Janssen Seeks European Approval of BCMA CAR-T Therapy

FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Merck’s Keytruda Approved in Combination with Trastuzumab and Chemotherapy for Cancer Treatment

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

 FDA Gets Tough on Sponsors Not Reporting Clinical Trial Results 

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

Pharma Prices and Patents Under Attack

FDA has approved AstraZeneca’s Farxiga (dapagliflozin) for treating chronic kidney disease in the United States.

FDA Approves AstraZeneca’s Kidney Disease Treatment

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

GSK Gets EC and FDA Approval for Endometrial Cancer Biologic, Jemperli

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies. 

Responding to FDA CAPA Requests 

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

FDA and Industry Move to Renew New Drug User Fee Programs

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Regulatory Oversight and Compliance