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In an effort to help pharma manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.
The FDA is changing its generic drug review policy, abandoning its "first come, first served" approach when there is a potential public health risk to ensure that these submissions are not delayed, the agency said.
Pfizer is joining the ranks of vaccine manufacturers, with the purchase of a company developing technology that boosts the immune system by shooting microscopic DNA-coated gold particles into the skin.
The FDA does not do a good enough job in making drug development information available to the public, and proposals for clinical-trial registries do not go far enough to address this problem, the activist group Public Citizen said in a study published in the Duke Law Journal.
The FDA has approved the first treatment in a class of new diabetes drugs that improve the body's ability to decrease high blood-sugar levels, giving drug manufacturer Merck another potential blockbuster to add to its portfolio.
Bristol-Myers Squibb has significantly strengthened its bleeding risk warning for patients on its blood-thinner Coumadin by adding a "black box" warning to the product's label, according to revised labeling posted on the FDA website.
Investigators studying a hypotension drug entered identical electrocardiogram (ECG) recordings for readings taken several weeks apart, while other staff reported that they had performed procedures on more than one subject at the exact same time, according to an FDA warning letter.
The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule issued Oct. 17 to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.