Latest Federal Register Notices
DEVICES
Public Meeting on Device User Fees Reauthorization
Federal Register Notice: FDA has announced an 11/2 public meeting on “Medical Device User Fee Amendments (MDUFA)” that will discuss proposed recommendations for reauthorizing the program for fiscal years 2018 through 2022. The current legislative authority for MDUFA expires 10/1/2017. The meeting will be held at FDA’s White Oak campus (Silver Spring, MD). After the meeting, public comment will be accepted for 30 days. To view this notice, click here.
FDA Seeks Nominations for Device Patient Engagement Panel
Federal Register Notice: FDA has begun accepting additional nominations for members to serve on CDRH’s Patient Engagement Advisory Committee. The panel provides perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. To view this notice, click here.
Microbiology Devices Panel to Meet 11/9-10
Federal Register Notice: FDA has announced an 11/9-10 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting in Gaithersburg, MD. On 11/9, the panel will vote on the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from Class 3 (premarket approval) to Class 2 (510(k)). It will also make recommendations on the appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus, BK virus, JC virus, Human Herpes virus 6, and Adenovirus infections. On 11/10, the committee will discuss and make recommendations on how FDA might handle a future premarket notification (510(k)) submission for a procalcitonin test. To view this notice, click here.
DRUGS
List Revised on Drug Products That Can't Be Compounded
Federal Register Final Rule: FDA has amended its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on the list may not be compounded under exemptions allowed in the federal Food, Drug, and Cosmetic Act. To view this rule, click here.
Guidance on Developing Drugs for Head Lice
Federal Register Notice: FDA has made available a guidance on “Head Lice Infestation: Developing Drugs for Topical Treatment.” the document is intended to assist sponsors with their the overall development program and clinical trial designs of drugs to support such drugs. To view the guidance, click here. To view this notice, click here.
Guidance on Tropical Disease Priority Review Vouchers
Federal Register Notice: FDA has announced the availability of a guidance on “Tropical Disease Priority Review Vouchers” that outlines the agency’s interpretation of the program. The document discusses how priority review vouchers are awarded and how they apply to future applications for sponsors to seek a priority review. To view the guidance, click here. To view this notice, click here.
Public Meeting on Opioid Abuse-deterrent Properties
Federal Register Notice: FDA has announced a 10/31 to 11/1 public meeting in College Park, MD to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting is intended to obtain stakeholder input on the approach to testing FDA recommended in its draft guidance “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.’” The meeting will also provide an opportunity to discuss agency efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. To view this notice, click here.
Final Rule on 505(b)(2), ANDA Patent Certifications
Federal Register Final Rule: FDA has issued a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) that applies to 505(b)(2) NDA applications and ANDAs. The rule covers the provision of notice to each patent owner and NDA holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month approval stays; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support them. To view this notice, click here.
FDA Adds More Bioequivalence Recommendations for ANDAs
Federal Register Notice: FDA has announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations for studies to support ANDAs. abbreviated new drug applications (ANDAs). To view the listing of BE recommendations, click here. To view this notice, click here.
Pharmacy Compounding Committee to Review 5 Bulk Drugs
Federal Register Notice: FDA has announced an 11/3 Pharmacy Compounding Advisory Committee meeting at the agency’s White Oak campus (Silver Spring, MD). The committee intends to discuss five bulk drug substances nominated for inclusion on the agency’s listing of bulk drugs for use in compounding — glycolic acid, trichloroacetic acid, kojic acid, diindolylmethane, and vasoactive intestinal peptincyde. To view this notice, click here.