« Previous
Next »
Titles
- 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
- Chronic hepatitis B virus infection: developing drugs for treatment1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry1
- Competitive generic therapies1
- Competitive generic therapies: guidance for industry1
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards1
- Considerations for the development of dried plasma products intended for transfusion1
- Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1