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.
Two drug companies are pushing back against proposed FDA guidance that would require drug sponsors to hold pre-trials to determine whether patients with a nasty form of esophageal swelling could benefit from an alternate therapy. Read More
British regulators will continue to issue EU-required Certificates of Pharmaceutical Product (CPPs) even if there is no formal Brexit agreement, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said on Monday. Read More
The House and Senate will each take a hard look at drug prices Tuesday, one in a mark-up that would require drugmakers to make public justifications for price increases or high launch prices, the other in a hearing that will gather executives from some of the nation’s largest pharmacy benefit managers. Read More
Three drugmakers have agreed to pay nearly $123 million to settle separate claims that they defrauded the government through an elaborate kickback scheme involving charitable foundations. Read More
Oklahoma Attorney General Mike Hunter has dismissed most of his state’s case against Johnson & Johnson and Teva, winnowing down a landmark opioids lawsuit to a public nuisance complaint. Read More
Ned Sharpless officially stepped into the position of FDA acting commissioner today, following former commissioner Scott Gottlieb’s resignation, effective last Friday. Read More
The FDA on Thursday released final guidance on how the agency will weigh the legally required factors when considering whether to require a risk evaluation mitigation strategy for medicines. Read More
The FDA and Customs and Border Protection are teaming up to help crack down on illegal opioids flooding the country, Commissioner Scott Gottlieb announced Thursday. Read More
HHS Secretary Alex Azar on Thursday asked Senators for their support for rule changes that would redirect prescription drugs discounts toward customers. Read More
FDA Commissioner Scott Gottlieb is leaving the agency on Friday to rejoin the American Enterprise Institute—a conservative think tank—where he will work part-time on drug pricing issues. Read More