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Titles
- Referencing approved drug products in ANDA submissions2
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin1
- Assessing user fees under the prescription drug user fee amendments of 20171
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees1
- Chemistry, manufacturing, and controls changes to an approved application: certain biological products1
- Competitive generic therapies1
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards1
- Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers1
- FDA oversight1
- Field alert report submission: questions and answers1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA1
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency1
- Providing regulatory submissions in alternate electronic format1
- Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling1
- Providing regulatory submissions in electronic format: standardized study data1
- Qualification process for drug development tools: guidance for industry and FDA staff1