As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceCompliance...
On July 1, 2019, FDA published guidance on the content development and format of Instructions-for-Use documents (IFUs) to be submitted with a new drug application (NDA) or a biologics license application (BLA). The guidance was written to help applicants develop consistent content and formats ...
FDA expects an ANDA holder to update its labeling after the agency has approved relevant changes to the labeling for the corresponding RLD. By facilitating prompt submission of labeling changes to unapproved ANDAs to conform to RLD labeling updates, the agency expects this guidance ...
Food and Drug Administration (FDA) issued its Draft Guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods, which outlines recommendations for naming plant-based alternative foods for egg, seafood, poultry, meat, and dairy products (excluding milk). Specifically, the draft ...
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an...
The U.S. Food and Drug Administration (FDA) has issued new guidelines for protein analog producers in order to support the fast-growing sector. The guidance most pertinent to the alt-protein industry is around how to label plant-based analogs of foods that are ...
(CBER) releasedSafety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Guidance for Industry. The purpose of this guidance is to minimize medication errors and protect the end user. The FDA defines the end user as the patient, the patient’s...
FDA Issues Guidance on Biosimilar Labeling Susan Haigney September 18th 2023 The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act. ...
Legal guidance with respect to FDA enforcement actions including FDA seizures, injunctions, and investigations Example: Manufacturer and Distributor of a New Dietary Supplement Product Here is a case example of the way we might handle a particular legal project. One of our law firm's clients cal...
Guidance for industry: how to comply with the Pediatric Research Equity Act. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM077855.pdf. Accessed October 10, 2011 6. US Department of Health and Human Services; Food and Drug Administration. New molecular entities...