Drugs

Updated CDER/Office of Inspections and Investigations Operating Concept

FDA has published an updated Concept of Operations outlining how CDER and the Office of Inspections and Investigations (OII) (formerly the Office of Regulatory Affairs) “collaborate in a coordinated, programmatically aligned environment regarding marketing application assessment, inspections, and related activities.” The document covers preapproval, postapproval, surveillance, and for-cause inspection processes.

The agency says that included in the revision are establishment and drug evaluation processes using Remote Regulatory Assessments. It also incorporates establishment evaluation processes using inspection information from regulatory partners with which FDA has entered into mutual recognition agreements.

The document says the revised operating model allows FDA to better handle the growing complexity of the drug manufacturing landscape and to meet new challenges by:

ensuring consistency, efficiency, and transparency in establishment evaluations, inspections, and regulatory decision-making for human drugs across FDA;
advancing strategic alignment across CDER and OII functional units by updating and clarifying roles and responsibilities;
improving FDA’s operational capacity and efficiency by enhancing collaboration and reducing redundancy between various CDER and OII offices after the 10/2024 reorganization;
enhancing the quality of, and increasing access to, establishment and regulatory decisional information across FDA; and
meeting user fee commitments and improving the timelines for regulatory actions to protect public health and promote drug quality, safety, and effectiveness.

Woodcock: Ways to Make Gene Therapies More Viable

Former FDA principal deputy commissioner, acting commissioner, and CDER director Janet Woodcock says reforms are needed to make individualized gene therapies a viable development opportunity for rare diseases. Writing in a BioCentury online commentary, Woodcock says FDA already has the statutory authority to address several of the barriers preventing the

Vanda, FDA Clash Over Animal Testing Requirements

Vanda Pharmaceuticals and FDA are asking a federal judge to resolve a dispute over the agency's partial clinical hold on a yearlong trial of tradipitant for gastroparesis, with the company arguing that FDA's insistence on additional animal toxicity testing violates the FDA Modernization Act 2.0

Revised Guidance on Drug-Delivery Device Performance Requirements

FDA has issued a revised a 6/2024 draft guidance outlining the performance characteristics manufacturers should evaluate, validate and control for medical devices used to deliver drugs and biological products, including drug-device combination products. The guidance, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological

FDA Warns Chirp Innovations Over Unauthorized Pain Claims

FDA has issued a Warning Letter to Utah-based Chirp Innovations LLC for promoting its cleared Halo Wireless Muscle Stimulator for menstrual pain without obtaining additional marketing clearance and for widespread deficiencies in its quality system and medical device reporting procedures. The 10/2 Warning Letter followed an 11/2025

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Woodcock: Ways to Make Gene Therapies More Viable

Vanda, FDA Clash Over Animal Testing Requirements

Revised Guidance on Drug-Delivery Device Performance Requirements

FDA Warns Chirp Innovations Over Unauthorized Pain Claims