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The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients. Read More
Generic drug giants Teva and Mylan are just some of the 13 companies tapped by the FDA to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ U.S. product imports expedited treatment. Read More
The China Food and Drug Administration is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there. Read More
Troubled drug compounder and repackager Medisca has landed in hot water with the FDA again after the agency found a different type of drug in recalled lots of L-citrulline. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP, after a single glass particle was found in just one vial of a lot of the drug. Read More
Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More
Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
Israeli-owned RedHill Biopharma and Canada’s IntelGenx have received a complete response letter from the FDA for their RHB-103 migraine drug, which cites problems with the pharma partners’ third-party chemistry, manufacturing and controls, packaging and labeling issues. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Wednesday revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
The FDA has selected 13 drugmakers to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More