A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...
Forbes contributors publish independent expert analyses and insights. Fred L. Smith Jr. Fellow at the Competitive Enterprise Institute. The 2024 Federal Register hit 86,712 pages October 30, the third ...
On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the ...
FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is probably the most used ...
China and the EU have agreed on price undertaking guidance for Chinese battery electric vehicles (EVs) makers, China's Ministry of Commerce (MOFCOM) announced on Monday, marking a significant step ...
I’ve been pouring over federal guidance documents for 20 years as part of my research on American public policy. Sound boring? It’s actually fascinating, because reading these documents, which touch ...
The Consumer Financial Protection Bureau (CFPB), which is undergoing significant changes under the Trump administration, has rescinded 67 guidance documents issued since 2011, including several that ...
“The USPTO’s ‘Apparent Authority’ guidance is a classic case of a rule that has no reason to exist at all. It creates $30 to $40 million per year excess burden on the public because the USPTO skipped ...
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