Drugs
FDA has released a guidance on “Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process” for panels convened to determine whether a sunscreen active ingredient or combination of sunscreen active ingredients is generally recognized as safe and effective and should be added to the over-the-counter( OTC) sunscreen drug
Drugs
FDA has approved Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for an oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received an orphan drug designation for this indication and will be the first available intravenous formulation of
Devices
FDA has cleared a Teleflex 510(k) to market its Arrow JACC with Chlorag Technology and TightTrack tunneler, a small french-size antithrombogenic and antimicrobial central venous catheter designed to meet the needs of patients throughout their course of therapy or illness. The device is also designed for use with
Devices
FDA needs to stop delaying a “a much-needed – and supposedly top priority – guidance” on clinical decision-support software, according to Clinical Decision Support Coalition counsel and Epstein Becker & Green partner Bradley Merrill Thompson. The agency has been working on the guidance for five years, but it still hasn’
FDA Policy/General
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/
Devices
FDA has released a guidance on “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” that describes studies and criteria that FDA recommends be used when submitting 510(k)s for such devices. The document is intended to guide manufacturers in conducting appropriate performance studies and preparing submissions.
Devices
FDA has approved a St. Jude Medical PMA for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s
FDA Policy/General
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’
Devices
FDA has posted a guidance on “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” that describes studies and criteria the agency recommends when submitting 510(k)s for such devices. The document is intended to guide manufacturers in conducting appropriate performance studies and preparing submissions. The guidance
Biologics
FDA has accepted a Coherus BioSciences BLA for CHS-1701, a pegfilgrastim (Amgen’s Neulasta) biosimilar candidate. The product is indicated for helping to reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer
Devices
FDA has cleared an Adapta Medical 510(k) for the PerfIC Cath intermittent touchless urinary catheter. It is designed for those with a spinal cord injury, multiple sclerosis, diabetes, stroke, spina bifida or other conditions that require a catheter. The device features a patented gripping accessory and hydrophilic coating to
FDA Policy/General
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
Devices
FDA has cleared a Fresenius Kabi 510(k) for the Aurora Xi Plasmapheresis System for use in collecting plasma. “The Aurora Xi system features a proprietary filtration-separation method that enables the faster collection of Source Plasma,” the company says. The device also includes an interactive touch screen, data management
Drugs
Flamel Technologies has reached agreement with FDA for a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial of FT218, a once nightly formulation of sodium oxybate that uses the company’s proprietary drug delivery platform, Micropump. The Phase 3 trial, entitled “A Double-
Drugs
Alnylam Pharmaceuticals has decided to discontinue developing revusiran, an investigational RNA interference therapeutic being developed for treating hereditary amyloid transthyretin amyloidosis with cardiomyopathy. The decision was based on a data monitoring committee (DMC) recommendation involving a Phase 3 study called ENDEAVOUR. The DMC did not find conclusive evidence for a
Devices
FDA has cleared a Trice Medical 510(k) for mi-eye 2, a disposable needle with an integrated camera that enables physicians to use advanced diagnostic imaging to visualize joint injuries in their clinic. The device is designed for use in diagnostic and operative arthroscopic and endoscopic procedures to provide
Devices
FDA has cleared a Xenocor 510(k) for the Xenoscope, a single-use disposable laparoscope that will be offered in a sterile condition. The device provides high-definition, real-time image acquisition, and is designed to be used in remote and extreme environments without a power grid, according to the
FDA Policy/General
The Animal Legal Defense Fund (ALDF) is claiming victory in a 9th Circuit Court of Appeals decision that sent an ALDF case against FDA involving factory egg farm statistics back to a lower federal court for trial. A full panel of appeals court judges set precedent, ALDA says, by providing
Drugs
FDA has approved an Orexo U.S. supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) 0.7mg/0.18mg for treating patients with opioid dependence. The approval adds a new dosing option to Zubsolv’s existing approved dosing range that includes 11.4mg/2.9mg, 8.6mg/2.1mg, 5.
Drugs
A split vote (15 to 13) by FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has recommended increasing the minimum dose for injectable and intravenous administration of naloxone for treating overdoses outside of a hospital or medical setting. Panel members said
Drugs
CDER has appointed a National Institutes of Health (NIH) official as director of its Office of Medical Policy (OMP). Center director Janet Woodcock says that Jacqueline Corrigan-Curay will start on 10/16. In an announcement to Center staff, Woodcock said that Corrigan-Curay “brings to the position a unique
Devices
FDA has cleared a Viveve Medical 510(k) for the Viveve System for use in general surgical procedures for electrocoagulation and hemostasis in treating vaginal laxity. The device uses patented radiofrequency (RF) energy to stimulate the body’s natural collagen rebuilding processes in the vagina. A physician performs the procedure