Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is ...
The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...
An FDA panel pushes reclassify testosterone therapy by recommending removal of controlled substance status and expanding treatment eligibility.
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FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates
WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...
In its latest PFDD installment, the FDA offers a detailed roadmap for sponsors seeking to design, adapt, or validate COAs that accurately ...
It’s getting out of control. It’s distorting the doctor-patient relationship, these endless pharmaceutical ads,” Makary told “Pod Force One” host Miranda Devine.
In October 2025, the FDA released a revised guidance titled, “Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers.” ...
On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...
Tweets would have to include all risks and benefits. — -- Tweeting about the most commonly prescribed drugs will be nearly impossible if new FDA guidelines on the use of social media by drug and ...
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