Devices
An 8/24-8/27/15 FDA inspection at the Sorin Group manufacturing facility in Munchen, Germany, identified Quality System Regulation and other violations in the firm’s manufacturing of Stockert Heater Cooler 3T thermal regulator devices. A 12/29/13 Warning Letter says that specific violations noted on an
FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee 1/12 will vote on Robert Califf’s nomination to become the next FDA commissioner. While his earlier nomination hearing was relatively supportive, Califf was grilled by committee member and presidential candidate Bernie Sanders (I-VT), who is concerned about his previous
Devices
FDA has issued a medical device safety communication urging healthcare providers in Puerto Rico and staff at healthcare facilities or hospitals in Puerto Rico not to use Customed convenience packs and trays for any surgical procedures. The notice says that the integrity, safety and efficacy of the products can’t
Devices
Lanx, Inc., a spinal fixation device maker, won a product liability case in Mississippi last month by relying upon, among other defense arguments, the Buckman U.S. Supreme Court decision on federal preemption. In Estes v. Lanx, Inc., plaintiff Rocky Estes underwent spinal fusion surgery in 2011 that used the
Drugs
Some seven academic and government researchers in the U.S. say that despite a growing movement to encourage reproducibility and transparency practices in the scientific community, including public access to raw data and protocols, the conduct of replication studies, systematic integration of evidence in systematic reviews, and documentation of funding
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals. Comments should be submitted by 3/21.
FDA Policy/General
Federal Register Notice: FDA is making available a draft document entitled Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry. It provides certain establishments that manufacture non-
Devices
FDA has reclassified from Class 2 to Class 3 surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The agency is also requiring these product manufacturers to now submit a PMA to support their device’s safety and effectiveness. “The orders will require manufacturers to address
Devices
A draft guidance on “Unique Device Identification (UDI): Convenience Kits” outlines a narrower interpretation of convenience kits that are exempt from bearing UDIs on the individual components. Under FDA’s 2013 UDI final rule, devices packaged within the immediate container of a convenience kit are excepted from UDI labeling requirements
Drugs
Three Johns Hopkins researchers say that because FDA approves the generic products that establish competitive markets, the agency should have a more active role in ensuring that patients have access to essential drugs that have been affordable for many years. Writing in a Journal of the American Medical Association Viewpoint,
Drugs
Former CDER Office of Prescription Drug Promotion regulatory counsel Seth Ray has joined O’Melveny & Myers in the firm’s Washington office as senior counsel. Ray served at the agency for 26 years as associate deputy chief counsel for drugs and biologics and associate chief counsel for enforcement, where
Biologics
AbbVie has petitioned FDA asking that it ensure that any biosimilar interchangeability determinations meet the “safety standards for determining interchangeability” set forth in Public Health Service Act section 351(k)(4) with respect to each condition of use for which the reference product is licensed, regardless of whether the applicant
Drugs
Bipartisan leaders of the House Energy and Commerce Committee are asking the Government Accountability Office (GAO) to revisit its past evaluations of FDA’s oversight of foreign drug plants. In a 12/18/15 letter, the representatives say that while FDA has implemented many changes since 2010, “we are concerned
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection contained in its regulations on current good manufacturing practice for positron emission tomography drugs. Comments should be submitted by 2/29. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff. Its purpose is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT
FDA Policy/General
Federal Register Notice: FDA is announcing the Web site location where it will post two lists of guidance documents that CDRH intends to publish in Fiscal Year 2016. Also, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals. It describes the agency’s policy for notifying the public about medical device “emerging signals.” Historically, FDA has communicated important medical device postmarket information after having completed an analysis of available
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental NADA filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for ThromboGenics’ Jetrea (ocriplasmin) is 2,171 days for extending a patent which claims the human biological product. Jetrea is indicated for treating symptomatic vitreomacular adhesion. To view this notice, click here.
Drugs
A New York Times profile says that the approach taken by long-time FDA oncology chief Richard Pazdur to approving new cancer drugs has changed with his wife’s ovarian cancer diagnosis and 11/2015 death. The profile says that some cancer specialists say that Mary Pazdur’s three-year
Biologics
CBER has posted a draft guidance (XXXINSERT LINKXXX) on “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271.” The document provides recommendations and relevant examples for complying with the
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information entitled “Hearing, Aging, and Direct-to-Consumer Television Advertisements” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.