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The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset seizure (POS) drug efficacy from adults to patients one month and up. Read More
Congressman Jack Bergman (R-Mich.) joined bipartisan lawmakers, veterans and post-traumatic stress disorder (PTSD) experts to highlight the need for FDA approval of midomafetamine (MDMA) -assisted therapy to address the treatment of PTSD and veteran suicide. Read More
The FDA has opted to terminate CBER’s Allergenic Products Advisory Committee due to the expert group’s relative inactivity over the past few years, shifting its duties over to the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Read More
The FDA has issued final guidance on application fees for combination products, explaining that when a sponsor submits a single application for a combination product, the fee should be for that application. Read More
The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Read More
A Texas pharmaceutical marketer was sentenced to two years and five months in federal prison and ordered to pay over $59 million in restitution for conspiring to defraud the US, receiving illegal kickbacks in exchange for compounded medications prescription referrals, and money laundering. Read More
The FDA issued a complete response letter (CRL) to Novo Nordisk for insulin icodec — a once-weekly long-acting human insulin analogue — raising questions about the manufacturing process and the type 1 diabetes indication. Read More
Lost in the politics-oriented follow up to the presidential debate between Joe Biden and Donald Trump was the substance of what they both said during the debate about the actual issues — and a number of these issues potentially involve the FDA. Read More
The FTC submitted a comment supporting a proposed US Patent and Trademark Office (USPTO) rule to address patent system abuse such as the creation of overlapping patent rights known as patent thickets, which can block or delay competition, a problem especially apparent in bringing generics and biosimilar drugs to market. Read More
The nation’s largest pharmacy benefit managers (PBM) have drastically consolidated to a select and much-enriched few while wielding “enormous power and influence” over American consumers, the FTC illustrated in a 73-page report released Tuesday. Read More
To aid drug and device makers in battling misinformation about their products, the FDA has issued a 21-page question-and-answer draft guidance that provides firms with ways to address the issue. Read More