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The FDA will hold a public workshop in early May to discuss the development of standards for the interoperable exchange of information pertaining to prescription drug tracing. Read More
Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More
New authorities granted to the FDA in 2012 that stiffened penalties for drug counterfeiters are failing to curb the problem of fake drugs because they do not apply to distributors of counterfeits. Read More
Merck, Ferring Pharmaceuticals and the World Health Organization have partnered up to study a drug aimed at preventing excess bleeding during childbirth — the leading cause of maternal deaths during childbirth in developing countries. Read More
Mylan is accusing Celgene of violating federal antitrust law by prohibiting the generic drugmaker from obtaining samples of its blockbuster products Thalomid and Revlimid to make generic versions. Read More
ViiV Healthcare is licensing its HIV drug Tivicay to the Medicines Patent Pool in an effort to increase access to adults and children living with the virus. Read More
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
FDA approval of Stallergene’s under-the-tongue Oralair could be a huge boon for patients who suffer from hay fever and rake in billions more for the drugmaker, whose drug is already available in over two dozen countries. Read More