Drugs
Drug and biologics developers may benefit from a provision in the recently signed 21st Century Cures Act that allows FDA to rely on a “qualified data summary” — a clinical data summary that demonstrates the safety and effectiveness of a drug’s potential qualified indication — to support approval of new uses
Devices
FDA has granted a Roche de novo request to allow the marketing of its Anti-Müllerian (AMH) assay, what the company calls the first approved fully automated AMH test available in the U.S. to help women who are planning to become pregnant or struggling with infertility. The blood test
Drugs
FDA has canceled a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting to review a Neurocrine Biosciences NDA for Ingrezza (valbenazine) for treating tardive dyskinesia. FDA told Neurocrine that the priority review of the NDA is continuing as planned with a user fee target action date of 4/11, according
FDA Policy/General
Federal Register Final Order: FDA has reclassified surgical instrumentation for use with urogynecologic surgical mesh from Class 1 (general controls) exempt from premarket notification to Class 2 (special controls) subject to premarket notification, and identifying them as ‘‘specialized surgical instrumentation for use with urogynecologic surgical mesh.’’ FDA is designating special
Drugs
FDA has accepted for review an Ironwood Pharmaceuticals NDA for Duzallo (fixed-dose combination of lesinurad and allopurinol) for treating hyperuricemia in patients with uncontrolled gout. The user fee target action date is expected in the second half of the year. Lesinurad is a once-daily oral tablet that lowers
Devices
FDA has cleared an ivWatch 510(k) for its ivWatch Model 400 for pediatric patients under the age of 18. The device is a continuous monitor for a patient's intravenous line and provides early detection of an infiltration, when medication or fluid leaks outside the vein into the
Devices
The 1st Circuit Court of Appeals has affirmed a lower court ruling dismissing a suit that sought to argue fraud on FDA in a False Claims Act (FCA) case. Attorney James Beck (Reed Smith) writes in an online post that the decision in United States ex rel D’Agostino v
FDA Policy/General
FDA has accepted for priority review two Melinta Therapeutics NDAs for intravenous and oral Baxdela (delafloxacin) for treating patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA), according
Drugs
FDA has cleared a Luminex 510(k) for the Aries Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the agency has cleared for use on the Aries System. The company says that GBS infection is a leading cause of
Drugs
Harvard Medical School professors Aaron Kesselheim and Jerry Avorn say some provisions in the 21st Century Cures law emphasize speed and ease over science and could end up hurting patients and drug development. Writing in a Journal of the American Medical Association Viewpoint column, Kesselheim and Avorn say that while
Drugs
Lilly says that the research objectives and study approach for an FDA study of character-space-limited online prescription drug communication generally seem reasonable. The research is to examine two hypotheses, it says in a comment letter. The first is that participants who see substantive risk information in character-space-
Devices
CDRH has issued lists of guidance documents that it intends to publish in FY 2017 as well as previously-issued final guidances for which it wants to receive external feedback on whether they should be revised or withdrawn. The Web posting contains three separate lists: (1) an “A-List” of
Devices
Vermillion Labs says it has received a “clarification letter” from CDRH director Jeffrey Shuren stating that a 9/7/16 safety communication advising women and their doctors against using ovarian cancer screening tests for asymptomatic women does not apply to Vermillion’s FDA-cleared OVAI (MIA) and Overa (MIA2G) products,
Devices
Attorney Allyson Mullen (Hyman, Phelps & McNamara) says that in a finalized guidance on postmarket management of cybersecurity in medical devices, FDA appears to have changed the focus from “essential clinical performance” to “patient harm.” Writing in her firm’s FDA Law Blog, Mullen says the change from wording in
Drugs
Acorda Therapeutics is asking FDA to “carefully consider the sufficiency of the applicant’s identification and qualification of potentially genotoxic impurities in reviewing an ANDA referencing its Ampyra (dalfampridine) extended release tablets.” The company petition says that certain potentially genotoxic impurities that may be present in the Ampyra drug substance
Drugs
Public Citizen says that FDA should require changes to the labels for repaglinide-containing medications (Novo Nordisk’s Prandin and Prandimet) and clopidogrel (Bristol-Myers Squibb’s Plavix) to include information on what it says is a serious drug-drug interaction that could result in severe hypoglycemia. The advocacy group’
FDA Policy/General
Federal Register Notice: FDA has announced a 4/6 public workshop entitled “Emerging Tick-Borne Diseases and Blood Safety” that will discuss tick-borne pathogens that continue to emerge as threats to blood safety. It will also review the effectiveness of current and potential mitigation strategies, and theg eneral approach
Drugs
Washington Legal Foundation (WLF) says that FDA should ease its restrictions on manufacturer dissemination of truthful and non-misleading information about off-label uses of approved medical products. In 12/30/16 comments provided in response to an agency 9/1/16 formal request for input, WLF said that the
Devices
FDA has posted a YouTube video explaining how it is helping to further 3D printing while adhering to its mission of ensuring medical device safety and effectiveness. In an online post, Plastics Today says that FDA senior research engineer James Coburn “takes viewers on a whirlwind tour of current and
Drugs
FDA issued 14 complete response (CR) letters in 2016, the highest number since 2009, which contributed to the disappointing 22 new molecular entity approvals (see earlier story) last year, according to a final update by retiring CDER Office of New Drugs director John Jenkins. “Each application for a new drug
Drugs
FDA has issued Innocoll a refuse-to-file letter for Xaracoll, the company’s combination product candidate for treating postsurgical pain, because the submission was not sufficiently complete to permit a substantive review. In the letter, FDA indicated, among other things, that Xaracoll should be characterized as a drug/device
Devices
Nurse Assist, Inc. has begun a Class 1 recall of its Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. An FDA recall notice says the recall, which affects almost 400,000 units, is due to a potential contamination