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.
Sponsors of atopic dermatitis drugs for children don’t have to wait to test a drug’s safety or efficacy on adults before beginning pediatric trials, the FDA says in a new final guidance. Read More
Hundreds of hospital CEOs urged congressional leaders not to tighten eligibility for 340B drug discounts, saying proposed cuts in the program would limit their ability to serve patients and would have little impact on drug prices. Read More
A robust antibiotic development pipeline will require a combination of “push” incentives, or those that support research and development, and “pull” incentives, or those that attract more investment, Gottlieb said. Read More
Under a 2015 draft memorandum, states were expected to take action against a compounder that distributed “inordinate amounts” of compounded drugs interstate. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
AmerisourceBergen agreed to pay 44 states and the federal government $625 million to settle allegations that it distributed adulterated and unapproved drugs. Read More
FDA Commissioner Scott Gottlieb announced new guidance Tuesday to address efforts by branded drugmakers to use the citizen petition process to stifle competition. Read More
The FDA issued final guidance for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Read More