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FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Read More
The trial results showed the combinations did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. Read More
The FDA cited Impax Laboratories after an inspection revealed a significant discrepancy in the operational qualification of its packaging line’s tablet counter/elevator. Read More
The FDA issued a warning letter to Deserving Health International after an inspection of the drug manufacturer’s facility in Richmond, British Columbia in July revealed sterility problems, failure to verify the identity of drug components and other significant violations. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The FDA is mandating a new class warning and labeling changes for all gadolinium-based contrast agents — as well as requiring manufacturers to conduct additional human and animal safety studies. Read More
The PTO’s Patent Trial and Appeal Board dismissed a patent owner’s claims of sovereign immunity from the proceedings — in a move that might have implications for Allergan’s Restasis patent case involving a Native American tribe that is currently pending before the board. Read More