Latest Federal Register Notices
BIOLOGICS
FDA Seeks Collaborators for Anti-Virus Invention
Federal Register Notice: The invention listed in this document: Therapeutic and prophylactic anti-Influenza virus neuraminidase 1 (N1) antibody (CD6) with a novel epitope that spans neuramindase dimers, is owned by an agency of the U.S. government and is available for licensing in accordance with federal regulations to achieve expeditious commercialization of results of federally funded research and development. The neuramindase 1 (N1) subtype of NA is important because it is found in the two pandemic H1N1 influenza virus strains (1918 Spanish flu and 2009 swine flu) and the H5N1 avian influenza virus. Anti-neuramindase antibody CD6 is a novel antibody that spans a conserved 30 amino acid epitope across the lateral face of a neuramindase (NA) dimer. FDA is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. The subject technology may offer an alternative to therapeutic NA Inhibitors. To view this notice, click here.
FDA Removes 2 Biologic Licensing Regs
Federal Register Final rule: FDA is removing two regulations that prescribe procedures for the agency’s review and classification of biological products licensed before 7/1/72. It is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. To view this final rule, click here.
DEVICES
Guidance on Lamotrigine/Zonisamide Assays
Federal Register Notice: FDA is making available a guidance entitled Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays. This guidance document discusses information to be included in premarket notifications for zonisamide or lamotrigine assays. To download this guidance, click here. To view this notice, click here.
Guidance on Diagnostic Radiology
Federal Register Notice: FDA is making available a draft guidance entitled Display Devices for Diagnostic Radiology. It provides recommendations for the types of information that should be provided in premarket notification submissions (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance, when finalized, will replace a previously issued final guidance entitled Display Accessories for Full-Field Digital. To download this guidance, click here. To view this notice, click here.
Final Report Available of Device Reviews
Federal Register Notice: FDA is announcing Booz Allen Hamilton’s final evaluation report submitted as part of their independent assessment of the process for the review of medical device submissions. To view this notice, click here.
FDA Publishes Approved PMAs
Federal Register Notice: FDA is publishing a list of PMAs that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management. To view this notice, click here.
Guidance on Polyethylene in Orthopedic Devices
Federal Register Notice: FDA is making available a draft guidance entitled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. To download this guidance, click here. To view this notice, click here.
FDA Reclassifies Membrane Lung Devices
Federal Register Final order: FDA is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments Class 3 device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to Class 2 (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. To view this notice, click here.
Scalp Cooling System into Class 2
Federal Register Final order: FDA is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia’s classification. To view this final order, click here.
HUMAN DRUGS
CDER Seeks Participants for Site Tours Program
Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. The Center is inviting pharmaceutical companies interested in participating in this program to contact CDER. To view this notice, click here.
Workshop on Biomarkers in Traumatic Brain Injury
Federal Register Notice: FDA will hold a public workshop 3/3 entitled “Advancing the Development of Biomarkers in Traumatic Brain Injury.” It aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury. The workshop will be held from 8 a.m. to 5 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, Rm. 1503 (the Great Room, sections B and C), Silver Spring, MD. Contact Allison Kumar, 301-796-6369, email: Allison.Kumar@fda.hhs.gov. To view this notice, click here.
Compounding Advisory Committee to Discuss Bulk Drug Substances
Federal Register Notice: FDA’s Pharmacy Compounding Advisory Committee will meet 3/8-9 to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The nominators of these substances will be invited to make a short presentation supporting the nomination. On 3/9, the committee will discuss two categories of drug products nominated for the list of drug products that present demonstrable difficulties for compounding, metered dose inhalers and dry powder inhalers. The nominators who nominated the category of drugs or specific drug products in the category will be invited to make a short presentation supporting the nomination. The meeting will take place 3/8 from 8:30 a.m. to 4:30 p.m. and 3/9, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Cindy Hong, (301) 796-9001. To view this notice, click here.
OMB OKs Info on Drug Producer Registration
Federal Register Notice: FDA’s collection of information entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
OMB OKs Info on Sponsor Meetings
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Formal
Meetings with Sponsors and Applicants for Prescription Drug User Fee Act Products” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
Panel to Discuss Intercept NDA for Cirrhosis
Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee will meet 4/7, from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss an Intercept Pharmaceuticals’ NDA for obeticholic acid oral tablets for treating primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Contact Cindy Hong, (301) 796-9001. To view this notice, click here.
Conference on Pharmaceutical Users Software Exchange
Federal Register Notice: FDA and the Pharmaceutical Users Software Exchange will hold a public conference 3/13-15 entitled “The FDA/PhUSE Annual Computational Science Symposium” to help the broader community align and share experiences to advance computational science. FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them. The meeting will be held 3/13, from 3 p.m. to 7 p.m., and 3/14-15 from 9 a.m. to 5:30 p.m. at the Silver Spring Civic Building at Veterans Plaza, One Veterans Pl., Silver Spring, MD. Contact Chris Decker, css@phuse.eu. To view this notice, click here.
GENERAL
OMB OKs Info on Samples/Protocols
Federal Register Notice: FDA’s collection of information entitled “Request for Samples and Protocols,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.