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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
For fiscal 2017, the FDA approved 763 generic drug applications, beating the previous year’s record of 651 by 17 percent. An additional 174 were granted tentative approval. 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
The American Civil Liberties Union has sued the FDA over restrictions on access to abortion-causing drugs, saying the restrictions are not grounded in science. Read More
Gilead asked the Ninth Circuit Court of Appeals to put its ruling reviving a whistleblower suit against the drugmaker on hold while the company petitions the United States Supreme Court to hear the case. Read More
The FDA replaced its 2001 guidance on organizing electronic common technical documents for submission, updating its recommendations to industry with the ICH’s M4 guideline. Read More