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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
Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
Sponsors of clinical trials in the European Economic Area must begin posting summary results on the EudraCT clinical trials database starting July 21, another move in Europe’s shift toward greater clinical trial transparency. Read More
Actavis’ proposed generic version of Novartis’ dementia-treatment Exelon Patch infringes on the product’s patent, a federal judge ruled Thursday in a case that centered on whether a specific chemical ingredient was “obvious” to include in the drug. Read More
Tianjin Zhongan Pharmaceutical’s manufacturing facility in China failed to follow cleaning procedures and maintain records on equipment operations, according to an FDA warning letter that cites various current good manufacturing practice (cGMP) violations. Read More
SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More