We would like to highlight one of the Draft Guidance issued by the FDA this month.**The U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices. Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.
With the new drug listing regulation, all companies have been given a renewed opportunity to ensure their listings are complete and accurate. This includes the label uploaded to the drug listing. The FDA recently issued a warning letter to a company whose listing did not match the product in commercial distribution. Do keep in mind that the FDA requires all changes to a drug listing to be reported as soon as possible but no later than the June or December following the change. As of FDA FY 2018, all drug listings must be certified as accurate by 31 December of each year. Any listing that has not been updated or certified as accurate according to the regulation will be considered expired by the FDA in January of the following year.
Guidance Document updates on the FDA website:
CDER:
- Drug Products Labeled as Homeopathic**
- Information Requests and Discipline Review Letters Under GDUFA
- Drug Products, Including Biological Products, that Contain Nanomaterials
- Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
- Systemic Antibacterial and Antifungal Drugs – Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs
- Refuse to File – NDA and BLA Submissions to CDER
- Gluten in Drug Products and Associated Labeling Recommendations
- Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements
- Pediatric Rare Diseases – A Collaborative Approach for Drug Development Using Gaucher Disease as a Model
CDHR:
- Replacement Reagent and Instrument Family Policy for In-vitro Diagnostic Devices
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products
- Software as a Medical Device (SAMD) – clinical Evaluation
- Clinical and Patient Decision Support Software
CBER:
- Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research
- An Acceptable Circular of Information for the Use of Human Blood and Blood Components
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products – Minimal Manipulation and Homologous Use
- Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruziInfection in Blood and Blood Components
CDRH and CBER:
- The Least Burdensome Provisions – Concept and Principles
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
- Technical Considerations for Additive Manufactured Medical Devices
- FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
Posted in Drug and Device Corner, Drugs, Medical Devices.