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Human Drugs

Multiple Issues Seen in Polimeros y Servicios Inspection

FDA warns Costa Ricas Polimeros y Servicios about CGMP and other violations in its manufacturing of OTC drugs.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Balamurali K. Ambati, Haw Par Healthcare, Metuchen Pharmaceuticals, Polimeros y Servici...

Human Drugs

Pharma Most Poorly Regarded Industry: Gallup

An annual Gallup Work and Education poll shows the pharmaceutical industry is the most poorly regarded industry by Americans, falling below even the f...

Consent Decree with Two Tennessee Companies

FDA says a Tennessee federal judge entered a consent decree against two companies to prohibit them from distributing drugs, dietary supplements, or me...

Human Drugs

Latest Federal Register Notices

FDA Review has posted the Federal Register notices for the week ending 8/30/2019.

FDA General

Since Our last Issue ...

Industry news you may have missed since our last issue.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 8/30/2019.

Human Drugs

Novartis Plans BLA for Arzerra in MS

Novartis says it will file a BLA and seek other global approvals for its leukemia drug Arzerra (ofatumumab) and its use in treating relapsing forms of...

Federal Register

CDRH Seeks to Fill Vacancies on Device Panels

Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Device Good Manufacturing Practice Advisory Committee and the M...

Federal Register

Docket No. on Pediatric Rare Disease Corrected

Federal Register notice: FDA corrects the docket number in a 12/2017 notice entitled Pediatric Rare Diseases--A Collaborative Approach for Drug Develo...