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Titles
- Referencing approved drug products in ANDA submissions2
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- 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
- Competitive generic therapies1
- 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
- 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
- Qualification process for drug development tools: guidance for industry and FDA staff1
- Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency1
- Risk evaluation and mitigation strategies: modifications and revisions1
- The "deemed to be a license" provision of the BPCI Act: questions and answers1