Expert Weighs In On New FDA AA Guidance for Cancer
FDA approves Alzheimer's drug from Biogen, against experts' advice
The FDA is requiring the drug maker to conduct a follow-up study to confirm the drug's benefits for patients. If the study fails to show ...
In response to this tragedy, Congress enacted a new law that required evidence of safety before a drug product could be marketed. The new law included many ...
Questions & Answers for Consumers Concerning Infant Formula - FDA
What's New · What is an Infant Formula? · How does FDA regulate Infant Formulas? · Does FDA have nutrient specifications for infant formulas? · Does FDA approve ...
10903 New Hampshire Ave., Bldg. 71, rm. 3128. Silver Spring, MD ... unanticipated findings, and expert advice. We encourage sponsors to ...
This guidance assists sponsors of investigational new ... 31 See the FDA guidance entitled Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional.
The FDA has issued new ... cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin) ... Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for ...