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GlaxoSmithKline Tuesday announced it will begin paying doctors again to promote its products as part of changes to its policy for working with healthcare professionals (HCPs). The move reverses a 2013 decision to stop financially rewarding physicians to talk about its treatments. Read More
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