Titles
- Pediatric HIV infection: drug product development for treatment1
- Pediatric information incorporated into human prescription drug and biological product labeling1
- Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products1
- Policy clarification for certain fluoroscopic equipment requirements: guidance for industry and Food and Drug Administration staff1
- Premarket tobacco product applications for electronic nicotine delivery systems1
- Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk1
- Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products1
- Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff1
- REMS: FDA's application of statutory factors in determining when a REMS is necessary1
- Recommendation followup: vulnerabilities continue to exist in the HHS small business innovation research program1
- Recommendations for reducing the risk of transfusion-transmitted babesiosis1
- Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff1
- Refuse to accept policy for 510(k)s: guidance for industry and Food and Drug Administration staff1
- Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff1
- Risk evaluation and mitigation strategies: modifications and revisions1
- Safety and performance based pathway: guidance for industry and Food and Drug Administration1
- Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals1
- Smallpox (variola virus) infection: developing drugs for treatment or prevention1
- Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research1
- The Special 510(k) Program: guidance for industry and Food and Drug Administration staff1