REMINDER: we are currently in the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications.
The FDA, in their commitment to assisting industry in the development of affordable, available, generic drugs, and as part of the Drug Competition Action Plan, is working toward addressing and improving transparency with regard to potential generic applicants obtaining brand RLD samples for generic drug development. The significant issue of industry’s inability to obtain certain RLDs for generic drug development, those that are in limited distribution, is being addressed by the agency in part by posting a list identifying all drug products for which the FDA has received an RLD access inquiry related to limited distribution. Further information is available on the website.
In the October 25, 2019 issue of the Federal Register, FDA announced that it was withdrawing Compliance Policy Guide Sec. 400.400 “Conditions under Which Homeopathic Drug Products May be Marketed”, effective immediately. This CPG was issued in 1988 and has served as the mechanism by which the regulation of homeopathic drug products was enforced.
However, due to ongoing concerns about the safety of homeopathic drug products, the FDA determined that the CPG did not prevent unsafe products from reaching the market nor did it reflect the agency’s current thinking with regard to its risk-based approach to regulatory and enforcement action.
In addition to withdrawing the CPG, the FDA also revised the draft guidance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry that had been issued in 2017. The revised draft adds a definition for “homeopathic drug product”, incorporates additional information regarding safety issues that contributed to the development of the guidance and clarifies the agency’s intent to use risk-based factors to prioritize enforcement and regulatory actions involving homeopathic drug products.
In an effort to assist Applicants with supplying correct and complete facility information to the FDA for NDAs, ANDAs, BLAs and submissions associated to these applications, the FDA has published the Guidance Document Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Q & A. This guidance is intended to clarify Agency expectations regarding facility information that should be included in original NDAs; ANDAs; original BLAs; amendments; supplements; CMC supplements; and resubmissions to these submission types. It is the FDAs hope that this guidance document will reduce the frequency of IRs, RTFs and RTRs as well as increase the efficiency of the application assessment process. The document addresses form 356h, Module 3 and referenced DMF details.
Federal Register Vol 84, No 207, Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments. FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). FR Vol 84, No 206, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 052” (Recognition List Number: 052), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Guidance Document updates on the FDA website:
- Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination The purpose of this guidance is to describe an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), nonsignificant risk (NSR), or exempt from investigational device exemption (IDE) requirements.
- Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software A Type V DMF is intended for the submission of FDA-accepted reference information and supporting data that are not covered by DMF Types II–IV.
- Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of systemic drug products for the prevention of HIV-1 infection.
- Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment The purpose of this guidance is to help sponsors design and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products.
CDER & CBER:
- Electronic Submission of IND Safety Reports Technical Conformance Guide This document represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic.
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports This draft guidance describes the electronic format sponsors will be required to use when they electronically submit to the FDA investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions.
- Postmarketing Studies and Clinical Trials – Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act This guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, which authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under section 505(c) of the FD&C Act and biological products approved under section 351 of the Public Health Service Act.
- Drug Master Files Guidance for Industry This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)).
- Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products This guidance provides recommendations to applicants regarding requests for waivers, refunds, and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for drugs, including biological products.
- Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development (PFDD) guidance documents that FDA is developing to describe in a stepwise manner how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.
- Breast Implants – Certain Labeling Recommendations to Improve Patient Communication This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants.
- Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling This guidance document provides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.
- Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature.
- Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.
- Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus The FDA is providing blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV), as required under 21 CFR 610.40(e).
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion The FDA is issuing this guidance document to provide blood collection establishments and transfusion services, with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion.
- CVM GFI #171 – Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products or Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients This document describes how CVM intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies (biowaivers) for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media (water soluble APIs).
- CVM GFI #261 – Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs This guidance is intended for sponsors and potential sponsors interested in pursuing conditional approval of new animal drugs for certain major uses in major species.