In the ongoing effort to make more affordable drugs available to the public, FDA Commissioner Scott Gottlieb, MD issued a statement on the FDA’s efforts to assist in this process. Of particular note is the FDA’s commitment to ensuring generic drug developers have access to brand drug samples for their development process. You can read the commissioners statement here.
The U.S. House Energy and Commerce Committee has progressed with legislation to reform and modernize the OTC Monograph System. Included in this reform is a discussion of an OTC user fee program similar to that of PDUFA, GDUFA, and BsUFA. The FDA sees an OTC monograph user fee program as a means of resources that would encourage innovation and fund the necessary regulatory system update. Currently, each ingredient-specific monograph must be finalized through a multi-step public rulemaking process. This new legislation is proposing an administrative order process to replace the current procedures. EAS will keep you updated as this legislation evolves.
We want to bring to your attention the recently released Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance Document. In this guidance, the FDA articulates its enforcement approach for OTC sunscreen drug products that are being marketed without an approved application as well as those included in the final monograph (for which the effective date has indefinitely stayed.) We highly recommend reviewing this document to find out where your sunscreen products fall in regard to the formulation, testing, and labeling requirements and how this new enforcement policy may affect their continued marketing. To read FDA Commissioner Scott Gottlieb, MD’s statement regarding sun exposure and sunscreens, please follow this link.
The FDA has announced in the Federal Register Vol 83, No. 87 their final order regarding the General Hospital and Personal Use Needle Destruction Device. Effective 4 June 2018, this device will be renamed “sharps needle destruction device” and reclassified from a class III device (regulated under product code MTV) into class II (special controls) which will make it subject to premarket notification. The reclassification will lessen the burden on industry for marketing such devices while still ensuring reasonable safety and effectiveness for users.
The FDA has published in the Federal Register Vol 83, No 94 a proposed amendment to regulations concerning the classification of products as biological products, devices, drugs or combination products. The agency will be accepting e-comments on their proposed amendment until midnight ET 16 July 2018.
The FDA has a webpage dedicated to Drug Supply Chain Security Act readiness, please follow the link for further information. There have also been 3 draft guidance documents released in 2018 regarding the Drug Supply Chain Security Act. The link will bring you to the FDA page listing each of these documents.
Guidance Document updates on the FDA website
- Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment
- Facility Definitions Under Section 503B of the Federal FD & C Act
- Pediatric HIV Infection: Drug Development for Treatment
- Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease
- Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders
- Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment
- Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an OTC Monograph: Study Elements and Considerations
- Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax
- Bioanalytical Method Validation
CDER & CBER
- Assessing User Fees Under PDUFA of 2017
- Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the FD & C Act
- S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies – Focus on Microsampling, Q & A
- Documenting Electronic Data Files and Statistical Analysis Programs
- Registering with CVM’s Electronic Submission System
- Administrative Applications and the Phased Review Process