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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
- Competitive generic therapies1
- Competitive generic therapies: guidance for industry1
- Controlled correspondence related to generic drug development1
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- General principles for evaluating the abuse deterrence of generic solid oral opioid drug products1
- Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance1
- Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters1
- Orange Book: questions and answers1
- Prescription drugs and Medicare Part D: a report on access, satisfaction, and cost1
- State Pharmacy Assistance Programs vs. Medicare prescription drug plans: how do they contain rising costs?1
- The Medi-Cal prescription drug benefit: an overview1