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The FDA’s Office of Prescription Drug Promotion has warned Herndon, Va., drugmaker ASCEND Therapeutics US for distributing promotional cards about its EstroGel product that omit important risk information. Read More
Bipartisan leaders of the House Energy & Commerce Committee are asking the FDA why extended-release opioids require black box warnings and immediate-release versions of the painkillers do not. Read More
A study of nearly 28,000 women linked antidepressants Paxil and Prozac to a small increase in birth defects, but cleared three other antidepressants of such concerns. Read More
The FDA is requiring stronger label warnings for non-aspirin nonsteroidal anti-inflammatory drugs, after a comprehensive review of new safety information affirmed an increased risk of heart attack or stroke. Read More
The House of Representatives Friday approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More
Manufacturers may obtain marketing authorization based on less-than-comprehensive applications if they supplement their filings with clinical data. Read More
The FDA handed Gilead Sciences an eight-observation Form 483 for an array of production issues, including poor manufacturing instructions and processing procedures. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More