Drugs
AcelRx Pharmaceuticals, Inc. says it has received comments from FDA’s Division of Anesthesia, Analgesia and Addiction Products on its proposed protocol for a Phase 3 clinical study (IAP312) to assess the overall performance of Zalviso (sufentanil sublingual tablet system) for managing moderate-to-severe acute pain in adult patients
FDA Policy/General
PTC Therapeutics has completed its rolling submission to FDA of an NDA for Translarna (ataluren), an oral, first-in-class, protein restoration therapy for treating nonsense mutation Duchenne muscular dystrophy (DMD). According to the company, the therapy is designed to enable the formation of a functioning protein in patients with
Drugs
FDA’s draft guidance on Public Notification of Emerging Postmarket Medical Device Signals could have unintended consequences that may encourage medical device and drug companies to engage in more off-label promotions and lead to more unfounded product liability lawsuits, according to an online post from Reed & Smith attorney
Drugs
CBER has posted a draft guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The document is intended to help establishments that make eligibility determinations for donors of human cells,
FDA Policy/General
Federal Register Notice FDA will hold a public workshop 4/21 entitled “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids.” Participants will discuss the appropriate level of good manufacturing practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. The workshop will be
Devices
FDA has granted approval of a new indication for Integra LifeSciences’ Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care. The
Drugs
FDA has granted Stealth BioTherapeutics fast track status for MTP-131 (also known as Bendavia) for treating primary mitochondrial myopathy that is characterized by muscle weakness in patients with genetic mitochondrial diseases. The drug is currently being evaluated in the company’s MMPOWER trial, with results expected mid-year. The
Devices
Novocure has filed a PMA supplement for its second generation Optune system for treating glioblastoma patients. The portable device is designed to deliver “Tumor Treating Fields” (TTFields) therapy to patients with newly diagnosed and recurrent glioblastoma. Novocure says it designed the second generation system to improve the convenience and manageability
Drugs
Tufts Health Sciences says FDA should include more examples to help IRBs understand its draft guidance on “Minutes of Institutional Review Board (IRB) Meetings.” The document was released in November to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings by providing requirements for minutes and
Drugs
FDA has granted a priority review for an AbbVie supplemental NDA for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period for the draft guidance entitled: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, which was first announced in the 11/7/13 Federal Register.The agency hopes to receive updated comments and any new information. To view this
Devices
An amendment from Rep. Mike Fitzpatrick (R-PA) to overturn the U.S. Supreme Court’s landmark Riegel v. Medtronic decision and allow patients harmed by a PMA device to seek the same redress as anyone else in the courts was rejected 1/6 after it was ruled not germane
Drugs
Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization have jointly filed a citizen petition urging FDA to take certain actions related to biosimilar product labeling. Specifically, they ask FDA to ensure that biosimilar labeling should: 1. State that the product has been approved as a biosimilar for the
Drugs
Baxter International has recalled two lots of intravenous (IV) solutions due to the potential presence of particulate matter (insects). The issue was identified prior to patient administration and there have been no adverse events reported to date, according to the company. Affected products are 0.9% sodium chloride injection, USP,
Devices
Drager has begun a Class 1 recall of the PS500 battery power supply for its Evita V500 and Babylog VN500 Ventilators because a software issue causes shorter than expected battery run times. The software bug also prevents the appropriate alarm from sounding five minutes before the battery depletes its power
Drugs
Anacor Pharmaceuticals has submitted an NDA for crisaborole topical ointment, 2%, a non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4), for treating mild-to-moderate atopic dermatitis in children and adults. According to the company, crisaborole is a novel boron-containing small molecule believed to inhibit PDE-4 in
Drugs
While in a few cases genetic information has proved useful in screening and treating diseases, in general the broad application of genetic information has not yet been shown to be helpful, despite considerable hype suggesting imminent and overwhelming benefits. That’s the conclusion reached in a CardioBrief analysis of a
Devices
Are there alternative FDA regulatory approaches that could accelerate hearing aid device innovation? Current hearing aids on the market are notorious under-performers, so innovation in the technology is what the agency wants to explore at a 4/21 public workshop on “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.
FDA Policy/General
Federal Register Notice: FDA Office of Minority Health, Office of Women’s Health, CBER, CDER, and CDRH will hold a public meeting 2/29 seeking feedback and recommendations from patient groups, consumer groups, regulated industry, academia, and other interested parties on FDA’s progress in implementing the “Action Plan to
FDA Policy/General
Federal Register Final order: FDA is classifying the intravaginal culture system 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 intravaginal culture system’s classification. To view this final order,
FDA Policy/General
Federal Register Notice: FDA is amending the 11/23 Federal Register notice of a meeting of the Orthopedic and Rehabilitation Devices Panel to change the agenda on page 72972 to read in the first column as follows: The committee will discuss, make recommendations, and vote on information regarding the premarket
FDA Policy/General
Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 3/4, from 8:30 a.m. to 3 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will meet