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After nearly 25 years of trying to reach biologics manufacturer Chembiomed but getting no response, the FDA today revoked the Canadian firm’s license. Read More
The FDA is offering a four-month grace period to retail and hospital pharmacies that do not act as wholesale distributors to electronically exchange drug transaction information. Read More
The International Academy of Compounding Pharmacists is urging Congress to require the FDA to revise a memorandum of understanding outlining how states should regulate small compounders, saying the 30 percent a month limit on units sent to other states is unfair and unworkable. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said June 18. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said June 17. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More