FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to U.S. cosmetic regulation since the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted in 1938.

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...

FDA expands Dupixent approval for children aged 2 to 11 years with chronic spontaneous urticaria symptomatic despite H1 antihistamine use.

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...

Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling an openness to new approaches that haven’t been validated and the National ...

The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of ...