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The FDA has slapped two generic manufacturers with separate warning letters for not paying registration fees on their facilities under GDUFA. Read More
The FTC gave generics makers a boost last week in their fight to stop brand drugmakers from using REMS restrictions to block access to sample drugs the generics industry needs to prepare ANDAs. Read More
Australian pharmaceutical regulators have finalized an extensive list of drug products and risk statements that manufacturers of nonprescription drugs should use when changing their labels to meet a requirement that goes into effect at the end of next year. Read More
Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies. Read More
SAN DIEGO — Two years after it was launched, the FDA’s breakthrough therapy designation, and what qualifies as a breakthrough, continues to baffle drugmakers who have experienced a roughly 63 percent rejection rate in receiving the expedited designation. Read More
Each year, up to 20 percent of the U.S. population gets the flu, resulting in more than 200,000 flu-related hospitalizations and 36,000 deaths. Read More
The FDA and Customs and Border Protection (CBP) began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More