Devices
FDA commissioner Scott Gottlieb says that CareFirst BlueCross BlueShield and United Health Group have joined the agency’s Private Payor Program to participate in medical device manufacturer pre-submission meetings. In an FDA Voice blog post, Gottlieb writes that the program is a “voluntary opportunity for manufacturers to receive feedback
FDA Policy/General
Federal Register notice: FDA is seeking nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. The panel provides advice on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products, and may recommend
Drugs
FDA has granted Pfizer a breakthrough therapy designation for its investigational oral Janus kinase 3 inhibitor PF-06651600 for treating patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body. The designation was supported by positive results from a Phase 2
Devices
FDA has cleared a Captiva Spine 510(k) for its TirboLOX-L 3D-Printed Titanium Lumbar Cages. The device is features a dual layer organic lattice structure, according to the company. “This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture,” it says. “Titanium alloy
Devices
FDA says it is launching a Quality in 510(k) (Quik) Review Program pilot for some moderate-risk medical devices. The program will allow sponsors of certain moderate risk medical devices to use the FDA eSubmitter software to structure their 510(k) applications for submission to the agency. An agency
Drugs
FDA has accepted for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). The submission is based on data from the Phase 2 KEYNOTE-017 trial that evaluated the overall response rate
Drugs
Pfizer says it has publicly urged manufacturers of Biosimilar User Fee Act products not to be solely focused on similarity when meeting with FDA. It has said that sponsors should be discussing manufacturing, packaging, and filing questions with the agency as they would for any biological product. “This should be
Drugs
FDA has published a guidance, Physiologically Based Pharmacokinetic Analyses—Format and Content, to outline the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including NDAs, BLAs, or ANDAs. The document says the agency recommends including these six
Biologics
CBER has scheduled a 12/7 public workshop on Quantitation of AAV-Based Gene Therapy Products. A workshop announcement says it is to discuss best practices when measuring the concentration of AAV (adeno-associated virus) vectors and to provide FDA perspective on qualifying such assays. Workshop topics are to include
Devices
FDA says the 6/20 Vyaire Medical recall of 2,150 units nationwide of its Tri-Flo Subglottic Suction System due to risk of device breakage is a Class 1 recall. An agency notice says the units were distributed between 1/23 and 5/23. The notice says that healthcare
Drugs
FDA says HelloLife is recalling certain lots of four drug products — Neuroveen, Respitrol, Thyroveev, and Compulsin. An agency notice says the products are labeled as homeopathic and are being recalled due to microbial contamination. The products were manufactured, FDA says, at the King Bio Inc., facility in Asheveille, NC.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Physiologically Based Pharmacokinetic Analyses — Format and Content.” The document outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic analyses to FDA to support applications. To view the notice, click here.
Drugs
Janssen has submitted an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults. The company says the investigational, rapidly acting antidepressant works differently than currently available therapies for major depressive disorder. “Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people
FDA Policy/General
Federal Register notice: FDA has announced the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee. Authority for the committee will now expire on 8/27/2020. To view the notice, click here.
Drugs
Federal Register notice: FDA has renewed for two years the charter of the Endocrinologic and Metabolic Drugs Advisory Committee. The new charter will now be in effect until 8/27/2020. To view the notice, click here.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts in a guidance to clarify when and how the agency will consider waiving the requirement that an ANDA applicant use a single shared system (SSS) of elements to assure safe use with its reference-listed drug. “PhRMA supports
Devices
Helius Medical Technologies has submitted a de novo clearance request for its Portable Neuromodulation Stimulator (PoNS) device for treating chronic balance deficit due to mild-to-moderate traumatic brain injury. The submission is supported by clinical data from two double-blind, randomized, controlled trials demonstrating the PoNS device’s safety
Drugs
As part of a settlement approved by the Securities and Exchange Commission, Sanofi will pay $20.2 million to the U.S. government to resolve allegations the company violated the Foreign Corrupt Practices Act by making payments in several countries to officials and healthcare professionals to influence them and increase
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Zimmer Biomet, Warsaw, IN (8/24): FDA re-inspected the firm in April as a follow-up to a 2016 inspection and
FDA Policy/General
Info Collection on Testing FDA Communications Federal Register notice: FDA seeks comments on a new proposed information collection entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” 08/31/2018 Info Collection Extension of Device Labeling Federal Register notice: FDA submits to OMB an information collection extension
FDA Policy/General
American Diversified Holdings has reached an agreement to acquire Brazos Biomedical, a biomedical device development company based in Houston, TX. Brazos has a proprietary device, Auracis, in pre-clinical development to treat headache pain using transcutaneous electrical nerve stimulation technology. BioCryst Pharmaceuticals has announced a planned merger with Idera Pharmaceuticals.
FDA Policy/General
DEVICES FDA has approved a Stryker PMA for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms. The device is indicated for unruptured aneurysms which are more challenging due to their location and surrounding anatomy, according to the company. “The stent is designed to