Draft guidance from FDA includes information essential for the completion of ANDA applications.
FDA has released draft guidance on the content and format of abbreviated new drug applications (ANDAs) to assist in the preparation of ANDAs submitted to FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
The draft guidance outlines the requirements for each section of the Common Technical Document (CTD) format for product applications and identifies supporting guidance documents and recommendations issued by FDA to assist in preparing the submission. Information on what an applicant should include to ensure a complete, high-quality application is presented. Previously published guidance has been published by FDA on the filing process, including the refuse-to-receive standards.
The fee structure or payment of obligations under the Generic Drug User Fee Amendments (GDUFA), the submission and assessment of drug master files (DMFs), amendments to original ANDAs and changes being effected, or prior approval supplements are not addressed in the draft guidance.
Source: FDA.gov
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.