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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and device makers in battling misinformation about their products, the FDA has issued a 21-page question-and-answer draft guidance that provides firms with ways to address the issue.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
To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA), a risk management tool that supports the HF engineering process. Read More
Multiple and repeated violations found in Sun Pharmaceuticals’ Dadra, India facility during a December 2023 FDA inspection have resulted in a Warning Letter following the company’s inadequate responses to a Form 483 levied on it earlier this year. Read More
The FDA is proposing to adopt a new guideline from the International Council for Harmonisation (ICH) on the use of real-world data (RWD) in pharmacoepidemiological studies of drug, vaccine and other biologic products, including recommendations for high-level best practices for these studies. Read More
Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will comply with the US Supreme Court’s new decision on who ultimately is in charge of interpreting federal regulations — federal agencies or the courts and Congress. Read More