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CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in remarks on Wednesday to a House subcommittee. Read More
Positron emission tomography (PET) firm PETNET Solutions was hit with an FDA warning letter for serious violations including “a state of disrepair and lack of cleanliness” at its Woburn, Massachusetts facility. Read More
An FDA advisory committee voted 14 to two on Wednesday to recommend FDA approval of Agile Therapeutics’ birth control patch AG 200-15 (levonorgestrel/ethinyl estradiol). Read More
The U.S. Patent Trial and Review Board has invalidated an Antecip Bioventures patent for neridronic acid as a treatment for complex regional pain syndrome (CRPS). Read More
Eleven drugmakers agreed to pay the state of Illinois $242 million to settle a 2005 lawsuit over the wholesale prices of their prescription drugs. Read More
The FDA outlined new electronic submission requirements for sponsors of investigational new drug applications (INDs) that apply to certain IND safety reports, in a draft guidance released on Tuesday. Read More