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The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Read More
The trade association of the British drug industry dropped its legal challenge to new guidelines from national regulators that subject higher-priced drugs to an extra review under England’s single-payer National Health Service. Read More
The FDA strongly supports transitioning the opioid painkiller market toward abuse-deterrent formulations, Commissioner Scott Gottlieb told a Senate committee examining the abuse epidemic. Read More