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Titles
- Referencing approved drug products in ANDA submissions2
- Risk evaluation and mitigation strategies: modifications and revisions2
- A most excellent cure for the stone and gravel1
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- 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
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Assessing user fees under the prescription drug user fee amendments of 20171
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- Bioavailability studies submitted in NDAs or INDs: general considerations1
- 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