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Titles
- 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- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1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