Format and Content of a REMS Document Guidance for Industry
Format and Content of a REMS Document Guidance for Industry guidance provides updated recommendations for the format and content of a risk evaluation and…
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Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” ARAs such as antacids, histamine H2-receptor antagonists, and…
Read more →Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products FDA announced the availability of a final guidance for industry entitled “Smoking Cessation…
Read more →Cover Letter Attachments for Controlled Correspondences and ANDA Submissions
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications…
Read more →Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of pharmaceuticals. Immunotoxicity is, for the purposes…
Read more →Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry guidance is intended to help sponsors of investigational new drug applications (INDs) and…
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