Remove Clinical Pharmacology Remove FDA Approval Remove Testimonials Remove Virus
article thumbnail

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

FDA 40
article thumbnail

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

FDA 40