FDA CDER Updates
The latest guidances, approvals, and safety alerts from FDA CDER, curated by automated regulatory intelligence.
Establishes standardized E2B(R3) electronic transmission requirements for individual case safety reports (ICSRs), including detailed data elements and message…
Establishes temporary FDA policy for compounding certain starter parenteral nutrition products intended for neonates, aiming to maintain supply while…
Clarifies how pharmacokinetic studies in patients with impaired hepatic function should be designed and analyzed to support labeling recommendations, with an…
Clarifies FDA expectations for demonstrating therapeutic equivalence for approved drug products, with emphasis on the evidentiary basis used to support…
Clarifies the decision logic and evidentiary expectations for applicants determining whether a generic drug should be filed as an ANDA or supported via a…
Provides draft FDA recommendations on the design, qualification, and control of container closure systems (CCS) for human drugs and biological products…
Clarifies how FDA will conduct and manage formal meetings with sponsors/applicants for PDUFA-related products, including expectations for requests, agenda, and…
Topic: Status: Draft.
Topic: Status: Final.
Topic: Status: Draft.
Outlines FDA’s key considerations for designing, conducting, and monitoring clinical investigations involving psychedelic drugs, with an emphasis on patient…
Clarifies FDA expectations for demonstrating in vivo bioequivalence for topical dermatologic corticosteroid products, which may affect study design, bridging…
Establishes FDA’s expectations and process for conducting formal meetings with sponsors or requestors seeking advice on Over-the-Counter (OTC) monograph drug…
Submits next-generation sequencing (NGS) data to the FDA’s Division of Antiviral Products using an expected data submission structure and review-ready formats…
Provides draft FDA_CDER expectations for using Quantitative Systems Pharmacology (QSP) models to justify first-in-human (FIH) dosing by estimating the Minimum…
Outlines a draft master protocol framework for coordinating and managing multiple clinical studies supporting drug and biological product development…
Clarifies how to submit clinical trial datasets that allow FDA to evaluate whether immunogenicity affects a drug’s pharmacokinetics.
Questions and Answers draft addressing FDA Forms 3542 and 3542a is intended to clarify how respondents should complete and submit the relevant forms…
Clarifies FDA expectations for certain postapproval obligations and where ANDA applicants/holders can find supporting resources to meet ongoing regulatory…
Clarifies how drug and device manufacturers may communicate with payors, formulary committees, and similar entities regarding their products, including…