We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative that includes a dozen recommendations for improving the agency’s response going forward. Read More
Former FDA Commissioner David Kessler is set to become Operation Warp Speed’s new chief science officer as just a single day remains until the Biden presidency takes up the mantle for accelerating COVID-19 vaccinations and countermeasures. Read More
FDA veteran Janet Woodcock has reportedly been short-listed by the incoming Biden administration to serve as the agency’s next commissioner and will also likely serve as acting chief until the position is filled. Read More
The Endocrine Society, a large physicians’ group, is calling on policymakers to include government negotiation as part of an overall strategy to reduce insulin prices. Read More
The Pharmaceutical Care Management Association (PCMA) has filed a lawsuit to halt implementation of President Trump’s drug pricing policy that aims to prevent drugmakers and pharmacy benefit managers from negotiating rebates on prescription medicines. Read More
Eli Lilly CEO David Ricks has expressed concern that the new variant of the coronavirus that causes COVID-19 first reported in South Africa might be resistant to the company’s antibody treatment bamlanivimab. Read More
As the Biden administration prepares to take over on Jan. 20, HHS has issued three new regulatory policies that it says will increase transparency and efficiency for the agencies it oversees, including the FDA. Read More
Operation Warp Speed (OWS)’s chief adviser Moncef Slaoui submitted his resignation Tuesday but said he will stay on in that role for 30 days after Jan. 21 to support the incoming administration. Read More
A last-minute proposal by the outgoing Trump administration would weaken one of the few tools the federal government has to directly reduce the price of new prescription drugs. Read More
HHS announced yesterday it will no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot, but will distribute them immediately and give states two weeks to comply with new federal rules for dose allocation. Read More
The ongoing rifts between HHS and the FDA continued this week with confusion surrounding the department’s selection of James Lawrence as the agency’s chief counsel, just hours after FDA Commissioner Stephen Hahn announced a different pick to agency staff. Read More
AstraZeneca (AZ) has filed for EU approval of its COVID-19 vaccine and a conditional marketing authorization is expected in late January following a Jan. 29 meeting of the European Medicines Agency’s (EMA) expert panel on human medicines. Read More