Devices
FDA has cleared an Alere 510(k) for its Alere i RSV test for detecting respiratory syncytial virus (RSV) infection in children and adults. The test comes on the heels of the Alere i Influenza A & B and Alere i Strep A, and they all run on the Alere
Devices
FDA’s Microbiology Devices Panel has unanimously agreed that the benefits outweigh the risks for allowing over-the-counter (OTC) diagnostic tests for detecting Chlamydia trachomatis/Neisseria gonorrhoeae. The panel also agreed that benefits outweighed risks for OTC group A streptococcus tests. However, the panel did not come to an
Drugs
FDA says it continues to be concerned about citizen petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. In a just-posted report to Congress on such petitions, FDA complains about its expedited review and responses the statute requires
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Export of Medical Devices; Foreign Letters of Approval,” 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.
Devices
CDRH has updated its Web page on requests for an exception to use an alternative approach to meet requirements under the agency’s Unique Device Identifier (UDI) rule. According to the agency, a device labeler may submit a request for an exception from or alternative to the requirement for the
Drugs
Sagent Pharmaceuticals has recalled one lot of oxacillin for injection 10g (lot OXT512 — expiry 3/2017), which was manufactured by Astral SteriTech, due to a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron
Devices
FDA has approved an expanded indication for Edwards Lifesciences’ Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk
Drugs
FDA has granted Supernus Pharmaceuticals tentative approval for an sNDA requesting a label expansion for Trokendi (topiramate) XR to include preventing migraine headache in adults. The tentative approval is based on an outstanding pediatric exclusivity period which expires 3/28/2017. Additionally, the agency granted final approval to expand the
Drugs
FDA has granted Soligenix an orphan drug designation for dusquetide and its use in treating macrophage activation syndrome (MAS). Dusquetide has previously received an orphan designation for treating acute radiation syndrome. Dusquetide is an innate defense regulator, a new class of short, synthetic peptides that accelerates bacterial clearance and resolution
Biologics
Genmab has submitted a supplemental BLA for Darzalex (daratumumab) and its combination use with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who received at least one prior therapy. The company has asked for a priority review, and the agency granted a breakthrough therapy designation
Drugs
The Environmental Working Group is asking FDA to investigate whether ingredients and other technologies are being used to boost sunnscreen SPF claims by masking the skin reddening that the group says is the body’s warning sign of skin damage. An 8/18 letter says that such products “may encourage
Drugs
The National Institutes of Health (NIH) says that a recent survey found that many respondents would be willing to participate in the national Precision Medicine Initiative (PMI) Cohort Program, a longitudinal research program that aims to enroll one million or more U.S. residents to improve the ability to prevent
Biologics
Responding to an FDA request for comment on its forms FDA-3486 and FDA-3486A used to report biological product deviations and human cells, tissues, and cellular and tissue-based deviations in manufacturing, AABB asks that the forms be modified to be easier to use by its members and member
Drugs
Sage Products has expanded an earlier recall to include one additional lot of its Comfort Shield Barrier Cream Cloths due to contamination (Burkholderia cepacia) concerns. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, an FDA
Drugs
Victor Lamar Coates of Philadelphia has entered a guilty plea to charges of conspiracy to traffic counterfeit Viagra and Cialis and for smuggling, trafficking and introducing the misbranded prescription drugs into interstate commerce. Coates admitted to illegally distributing over 10,000 counterfeit and misbranded tablets, including tablets he illegally imported
Devices
Medtronic has notified healthcare professionals about the potential for vascular trauma with the use of its EnVeo R Delivery Catheter System. The company says that while the reports of vascular trauma it has received have been infrequent, they have included serious outcomes, including 19 patient deaths. The observed rate of
Drugs
Arbor Pharmaceuticals has recalled three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal on the blister packs. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process, a recall notice
Drugs
FDA has issued Portola Pharmaceuticals a complete response letter on its BLA for AndexXa (andexanet alfa), indicated for reversing anticoagulant activity of both direct and indirect Factor Xa inhibitors. The letter asks the company provide additional information related to manufacturing, and additional data to support inclusion of edoxaban and enoxaparin
Drugs
Attorney Jennifer Newberger (Hyman, Phelps & McNamara) says that a new pre-RFD (Request for Determination) process announced by the FDA Office of Combination Products (OCP) to provide a more interactive approach to product designation should be “unsettling” to any sponsor who has dealt with OCP. Writing in her firm’
Devices
Kentucky’s attorney general says the state has filed a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, for its allegedly deceptive marketing of surgical transvaginal mesh. “In Kentucky, more than 15,000 women had transvaginal mesh implanted without Johnson & Johnson and Ethicon providing sufficient
Devices
FDA has cleared a Levita Magnetics 510(k) for its Levita Magnetic Surgical System that is intended for use to magnetically retract and maneuver the gallbladder, reducing the number of surgical incisions. The device is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic
Drugs
The Critical Path to TB Drug Regimens says that an FDA draft guidance on infectious disease next generation sequencing laying out a regulatory pathway that better defines the regulatory requirements for next generation sequencing (NGS) will be helpful to those developing diagnostic devices for antimicrobial resistance, and tuberculosis in particular.