USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs
USFDA Guidance: Format and Content for OTC Monograph Order Requests
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
USFDA Guidance: Pharmacogenomic Data Submissions
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling