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Titles
- CMC postapproval manufacturing changes for specified biological products to be documented in annual reports2
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards2
- Referencing approved drug products in ANDA submissions2
- Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)2
- A.D. Cromartie: an oral history1
- ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin1
- Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry1
- Advanced prostate cancer: developing gonadotropin-releasing hormone analogues1
- Appeal options available to mammography facilities concerning adverse accreditation decisions, suspension/revocation of certificates, or patient and physician notification orders: guidance for mammography facilities and Food and Drug Administration staff1
- Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide: backwards and forwards compatibility1
- Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff1
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Assessing user fees under the Generic Drug User Fee Amendments of 20171
- Assessing user fees under the prescription drug user fee amendments of 20171
- Best practices for convening a GRAS panel: guidance for industry1
- Best practices in developing proprietary names for human prescription drug products1
- Bioavailability studies submitted in NDAs or INDs: general considerations1
- Bispecific antibody development programs1
- Boisfeuillet Jones: an oral history1
- CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry1