Pharmaceutical Policy

Reference 13 - M9 Biopharmaceutics Classification System-Based Biowaivers

Reference 14 - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage

Reference 15 - Evaluation of the effect of dabrafenib and metabolites on QTc interval in patients

Reference 16 - Evaluating the Role of Solubility in Oral Absorption of

Reference 17 - In Silico Modelling Approach for the Evaluation of

Reference 18 - Bioequivalence Studies for Generic Drug Development

Reference 19 - Improving the Dissolution Rate of the Anticancer Drug Dabrafenib

Reference 20 - Citizen Petitions and Petitions for Stay of Action Subject to Section 505q of the Federal Food Drug and Cosmetic Act

Reference 21 - Draft Guidance on Rifaximin

Reference 22 - Bioequivalence safety and tolerability of imatinib tablets compared with capsules

Suitability Petition from Argenta

Acknowledgment Letter from FDA DMB to Argenta