USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests
USFDA Guidance: Six Finalized Medical Devices Guidelines
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
USFDA Guidance: Distribution of Approved Naloxone Products -Immediately-in-Effect
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
USFDA: Annual Summary Reporting Requirements -Right to Try Act -Final Rule
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products
USFDA's New WebPage: For Complex Generics
USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
USFDA's Draft Guidance: Orange Book Questions and Answers