This draft guidance describes FDA's current thinking on determining whether to submit an Abbreviated New Drug Application (ANDA) under section 505(j) of the FD&C Act or a 505(b)(2) application, including criteria for choosing between the two pathways and how to seek FDA's assistance. This revised draft updates and supersedes the... The post Determining Whether To Submit an ANDA or a 505(b)(2) App…
This guidance describes FDA's current thinking on the use of Type VII Veterinary Master Files (Type VII VMFs), which are appropriate for the research and development of animal cells, tissues, and cell- and tissue-based products, gene therapies, and heritable intentional genomic alterations in animals.... The post Type VII Veterinary Master File for Research and Development and Risk Reviews appear…
Avance Biosciences is hiring a Scientific Account Manager in Houston, TX — a great next step for PhD-level scientists ready to trade the bench for a client-facing role. Build relationships with biotech and pharma leaders, present our analytical and bioanalytical capabilities, and grow your career with hands-on mentorship and structured training. Apply today and help us connect great science with …
This draft guidance provides a risk-based framework for evaluating the quality of container closure systems (CCSs) used with human drugs and biological products, including quality assessments and quality control of packaging materials and components. It applies to new applications, amendments, supplements, and legally marketed drugs under section 505G, and FDA... The post Container Closure System…
This guidance provides recommendations to sponsors and applicants of Prescription Drug User Fee Act (PDUFA) products on formal meetings with FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, including principles of good meeting management, procedures for requesting and conducting meetings, meeting types and formats,... The post Formal Meetings Between…
Avance Biosciences will exhibit at BioProcess International and Cell & Gene Therapy International 2026, highlighting analytical support for mRNA therapeutics and RNA vaccines, on/off-target analysis, biodistribution analysis, whole genome sequencing, and potency testing. Visit our team at Booth #1402 to discuss analytical strategies for advancing biologics and next-generation therapies... The pos…
Prior to approving an antimicrobial new animal drug application, FDA must determine that the drug is safe and effective for its intended use in the animal, including an evaluation of the potential microbiological effects of the drug residues on bacteria of human health concern.... The post CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Ef…
This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency's recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the... The post Biosimilar and …
FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments.... The post Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administrati…
This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS).... The post Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance …
