Reminder that the FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility Fee: $17,435. The annual fee is due no later than 1 June 2023.
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These submissions are made during the month of May.
The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA:
- Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
- Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
- Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
- Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
- Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).
The FDA has created the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) webpage. The agency suggests checking the new site often for updates on developments of the implementation of requirements.
Highlighted Guidance Documents
The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages.
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.
CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions
The purpose of this document is to provide guidance on the types of fees the Food and Drug Administration (FDA or the Agency) is authorized to collect under ADUFA and how to request waivers and reductions from these fees.
Draft Guidances – comment period open
DRAFT Over-the-Counter Monograph Order Requests: Format and Content
This guidance is intended to assist requestors in preparing OTC monograph order requests for submission to FDA under section 505G of the FD&C Act. This guidance provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies relevant guidance documents to assist requestors in preparing their OMORs.
COMMENTS MAY BE SUBMITTED BY 12 June 2023
DRAFT Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS).
COMMENTS MAY BE SUBMITTED BY 12 June 2023
This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed transdermal or topical delivery system (collectively referred to as TDS).
COMMENTS MAY BE SUBMITTED BY 12 June 2023
This guidance is the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers, 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.
COMMENTS MAY BE SUBMITTED BY 5 July 2023
All Guidance Documents can be searched on the FDA’s website.
Federal Register
FR Vol 88, No 65 Human User Safety in New and Abbreviated New Animal Drug Applications; Draft Guidance for Industry; Availability
Vol 88, No 66 List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
FR Vol 88, No 70 Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program
Meetings
Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
Date: May 2, 2023
Time: 1:00 PM – 3:30 PM ET
A Deep Dive: GDUFA III Scientific Meetings
Date: May 15, 2023
Time: 1:00 PM – 4:30 PM ET
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
Date: May 16, 2023
Time: 1:00 PM – 2:00 PM ET
An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
Date: May 24, 2023
Time: 9:00 AM – 2:00 PM ET
Public Meeting: Good Manufacturing Practices for Cosmetic Products (virtual)
Date: June 1, 2023
Time: 10:00 AM – 1:00 PM ET
Regulatory Education for Industry (REdI) Annual Conference 2023
Dates: June 5 – 9, 2023
Time: 8:40 AM – 4:30 PM ET daily
FDA Websites of Interest
Update on In-Person Face-to-Face ANDA Meetings
FDA announces new safety label changes for opioid pain medicines
Medical Device Development Tools (MDDT)
Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products public workshop hosted by FDA and the Center for Research on Complex Generics. 15 June 2023
Posted in Drug and Device Corner, Drugs, Medical Devices.