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Indian pharma giant Dr. Reddy’s is still in hot water with the FDA over its API manufacturing plant in Srikakulam, Andhra Pradesh, which netted the firm yet another Form 483 for serious violations. Read More
The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level serial numbers. Read More
Drug distributor Acetris Health prevailed yesterday in an appeals court ruling that the company can call its products U.S.-made even though the active pharmaceutical ingredients are sourced elsewhere. Read More
In comments to the FDA, drugmakers called on the agency to clarify in its draft guidance for biosimilar and interchangeable insulin products that the agency will still hold applicants to the current licensing standards. Read More
The FDA hit an over-the-counter drug manufacturer in South China with a Form 483 for multiple violations, including missing operating procedures. Read More
The Department of Justice plans to continue its investigation into anticompetitive activity in the generic drug industry, according to a senior DOJ official. Read More
The Trump administration’s fiscal 2021 budget proposal unveiled Monday seeks an increase of 4.5 percent for the FDA while cutting most other non-defense spending. Read More
The FDA confirmed that it has suspended inspections of Chinese drug manufacturing facilities until further notice in response to the coronavirus outbreak. Read More