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Quality issues and violations of FDA current good manufacturing practices are plaguing Hospira, triggering a series of recalls, contributing to a drug shortage and costing the drugmaker’s parent company a biosimilar license for a second time. Read More
Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More
A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More
The European Commission updated its 2011 action plan against antimicrobial resistance, pledging to boost research into new treatments and develop guidelines for the prudent use of the drugs. Read More
To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first. Read More