The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described…

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. Source: Drug Industry…

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…

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. Source: Drug Industry…

The FDA strongly supports transitioning the opioid painkiller market toward abuse-deterrent formulations, Commissioner Scott Gottlieb told a Senate committee examining the abuse epidemic. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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…

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. Source: Drug Industry Daily

Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Source: Drug Industry Daily

A Texas judge ruled state legislators are entitled to see details of Pfizer’s Medicaid pricing practices, denying a legal challenge by the drugmaker. Source: Drug Industry Daily