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In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance released yesterday. Read More
Rumors are circulating in Europe that the European Commission (EC) will decline to renew its COVID-19 vaccine contracts with AstraZeneca (AZ) and Johnson & Johnson (J&J) once they expire, and a commission spokesperson has given a less-than ringing endorsement of the vaccines. Read More
The U.S. Court of Appeals for the Fifth Circuit Tuesday rejected Impax Laboratories’ appeal of the Federal Trade Commission’s antitrust ruling against the company over a June 2010 agreement it had reached with competitor Endo Pharmaceuticals over Opana ER, Endo’s extended-release version of the opioid painkiller oxymorphone. Read More
FDA Acting Commissioner Janet Woodcock has denied that the FDA’s moves to delay several drug reviews are a sign that the agency is becoming less flexible in its evaluations, advising people not to read too much into the recent delays. Read More
Watchdog group Public Citizen has asked FDA to add recently banned weight loss drugs and antibiotics to the official list of drug products that were withdrawn or removed from the market for reasons of safety or effectiveness. Read More
A federal agency has drafted recommendations calling on Congress to require drugmakers to pay higher Medicaid rebates for high-cost specialty drugs until they complete confirmatory trials following accelerated approvals by the FDA. Read More
As Democratic lawmakers push ahead for legislation this congressional session aimed at lowering U.S. drug prices, PhRMA has come out with a seven-figure national ad campaign and a new policy agenda that puts forward ideas of its own for lowering the costs of drugs. Read More
An expert panel of the Centers for Disease Control and Prevention (CDC) is meeting today to review blood-clot incidents reported in a handful of patients who received Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine. Read More
The agency said the sponsors failed to respond to a Sept. 25, 2020, Federal Register notice that offered an opportunity to seek a hearing on the matter. Read More
The institute has invited comments by April 26 and said it may change its recommendations when its appraisal committee meets to consider the responses and prepare the final appraisal document. Read More
Eli Lilly has revised its supply deal with the U.S. government to focus on distributing the company’s COVID-19 antibody bamlanivimab along with another antibody, etesevimab — a combination that has proven to be effective against variant strains of the Sars-CoV-2 virus which causes COVID-19 infections. Read More
The FDA has selected Patrizia Cavazzoni as permanent director of the Center for Drug Evaluation and Research (CDER), a position previously held for many years by Acting Commissioner Janet Woodcock. Read More