FDA Guidance Documents
FDA Guidance Documents
Stay current with the latest FDA guidance documents affecting drug, biologic, device, and diagnostic development. Browse recently issued and updated guidance to identify evolving regulatory expectations, compliance considerations, and recommendations that may influence your development and testing strategies.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products...
This draft guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. When final, this guidance will represent FDA's current thinking. FDA is also withdrawing the guidance for...
FDA is announcing the availability of a final guidance titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions." This guidance provides recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices. It supersedes the guidance "Dental Composite Resin Devices--Premarket Notification [510(k)] Submissions" dated...
FDA is announcing the availability of a final guidance titled "Dental Curing Lights--Premarket Notification (510(k)) Submissions." This guidance provides recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental curing lights. It supersedes the guidance "Dental Curing Lights--Premarket Notification [510(k)] Submissions" dated March 27, 2006....
FDA is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements...
FDA is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements...
This draft guidance (GFI #256B) describes circumstances where FDA generally does not intend to take enforcement action against the compounding of animal drug products from bulk drug substances at facilities registered under sections 503B(b) or 510(b) of the FD&C Act operating under current good manufacturing practice (CGMP). It extends FDA's...
This final guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what TE codes indicate for multisource prescription drug products listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). This guidance finalizes the draft guidance of the same title...
This draft guidance provides recommendations for developing assays to evaluate potency as part of a potency assurance strategy for active immunotherapy products (ACTIMPs), including peptide- and protein-based ACTIMPs that are not cellular or gene therapy products. It supplements FDA's December 2023 draft guidance "Potency Assurance for Cellular and Gene Therapy...
This final guidance provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products, spanning regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical, and clinical pharmacology topics. This guidance finalizes the draft version issued in...
