Compounding and the FDA: Q & A

Why do some patients need compounded drugs?A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a...

OTC Monograph Reform: OTC Sunscreen Drugs

On This Page Date: December 15, 2021 Time: 3:00 p.m. – 4:00 p.m. ET Visit CDER Small Business and Industry Assistance PageABOUT THIS WEBINAROn September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its...

Sunscreen Innovation Act (SIA)

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law. Section 505G of the CARES Act reforms and modernizes the OTC drug review process. It also includes provisions that...