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Stephen Hahn was sworn in as the FDA’s 24th commissioner by HHS Secretary Alex Azar Tuesday evening and he will make his debut appearance as commissioner to the agency’s staff on Friday. Read More
Members of the Senate Judiciary Committee spent a good portion of a hearing on the opioid crisis yesterday grilling a senior Drug Enforcement Agency official on the agency’s tracking of opioids. Read More
The FDA’s Oncologic Drugs Advisory Committee voted 9-4 yesterday to recommend approval of Merck’s Keytruda (pembrolizumab) injection for treatment of certain patients with bladder cancer who are ineligible for surgery or have opted out. Read More
The House voted 297-120 yesterday to approve a fiscal 2020 federal budget that includes $3.16 billion in discretionary spending for the FDA — $91 million more than in fiscal 2019 — and a total agency budget of almost $5.8 billion including user fees. Read More
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in a draft guidance. Read More
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Read More
In a new draft guideline, the World Health Organization (WHO) offered recommendations on complying with data integrity, GMP documentation and recordkeeping requirements. Read More
The European Medicines Agency’s biggest pharmacovigilance challenge in the next decade will be evaluating on-market efficacy, according to senior agency officials. Read More
Sens. Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) question whether authorized generics can “deliver real savings” to consumers, in a new report that finds Eli Lilly’s own generic of its blockbuster insulin product, Humalog, is not available in most pharmacies. Read More
In a court filing, California’s Attorney General is pushing back against a last-ditch effort by generic drugmakers to block California’s new pay-for-delay law. Read More
PhRMA is suing the state of Oregon in federal court to block enforcement of two drug price transparency laws — including one set to go into effect on January 1. Read More