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The FDA is set to release a slew of product-specific guidances to help generic manufacturers demonstrate the bioequivalence between their proposed generic and the reference product. Read More
HHS has issued a new variation of its recently invalidated rule requiring drugmakers to offer discounts on orphan drugs sold to hospitals that serve the poor when the products are meant for non-rare conditions. Read More
Indian regulators are seeking information from six manufacturers of generic cancer drugs in preparation for setting price caps on the products, a move that one industry observer says was expected. Read More
The FDA cited a trio of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is “unjustified” in using a new law to enforce old violations. Read More
After initially rejecting FDA’s authority, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
A trio of European pharmaceutical trade groups is seeking greater clarity around the European Medicines Agency’s initiative to streamline the drug approval process through parallel reviews for both reimbursement and safety and efficacy. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More