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Inventia Healthcare, a drugmaker headquartered in Mumbai, India, was slapped with a Form 483 for serious violations at its Thane, Maharashtra facility, including poor data integrity. Read More
The FDA hit a drug manufacturer in Dresden, Germany with a warning letter for serious violations, including a lack of API and stability testing. Read More
California’s State Board of Pharmacy is considering a request to revoke or suspend McKesson’s wholesale permit for “excessively” supplying controlled substances to a children’s pharmacy that are not typically distributed to pediatric patients. Read More
The Department of Justice (DOJ) has indicted a former Taro Pharmaceuticals executive for allegedly conspiring to fix numerous generic drug prices. Read More
As confirmed cases of 2019-nCoV coronavirus topped 28,000 this week with 500 fatalities, two senators urged FDA Commissioner Stephen Hahn to ensure that drugs, devices and food imported from China remain safe during the coronavirus outbreak. Read More
As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance yesterday on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product. Read More