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The Government Accountability Office says FDA should develop a policy on starting and ending enforcement discretion for unauthoriz...[ Price : $8.95]
Aurobindo reports receiving a six-item FDA 483 after an inspection at its Unit VII oral drug manufacturing unit in Jadcherla, Hyde...[ Price : $8.95]
Pharmatech Associates managing director Stephanie Gaulding discusses the effects of an FDA proposed revision to the medical device...[ Price : $8.95]
Bristol Myers Squibb provides two-year results from its POETYK PSO long-term extension trial of deucravacitinib in adult patients ...[ Price : $8.95]
Federal Register notice: FDA announces a 6/7 public meeting entitled Financial Transparency and Efficiency of the Prescription Dru...[ Price : $8.95]
FDA says an appeals court decision in a case involving orphan drug exclusivity is likely to slow research and innovation into drug...[ Price : $8.95]
CBER director Peter Marks says he wants to continue the Operation Warp Speed attention and quick approval process given to Covid-1...[ Price : $8.95]
FDA approves an oral suspension formulation of Mitsubishi Tanabe Pharma Americas Radicava (edaravone) for treating adults with amy...