The administration’s plan to nominate Scott Gottlieb as FDA commissioner drew generally positive reactions on Capitol Hill and from drugmakers — but also some concerns from other stakeholders over his…

The FDA’s Office of Generic Drugs approved 61 applications in February, marking a slight uptick in generic drug approvals. Source: Drug Industry Daily

The FDA partially granted a petition filed on behalf of Purdue Pharma concerning generic versions of an extended-release opioid. Source: Drug Industry Daily

The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study…

PhRMA urged the HHS inspector general to create a new safe harbor in anti-kickback regulations to directly address value-based payments and rebates. Source: Drug Industry Daily

The White House Friday confirmed that Scott Gottlieb will be nominated as the next commissioner of the FDA. Source: Drug Industry Daily

The FDA served drug manufacturer Amneal Pharmaceuticals with a Form 483 after an inspection found the company failed to submit all adverse drug experience reports on time. Source: Drug Industry…

The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still…

A law firm has filed a citizen petition calling on the FDA to reduce delays in the appeals process for drug designations. Source: Drug Industry Daily

Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Source: Drug Industry Daily