Drugs
FDA has accepted for priority review a Karyopharm Therapeutics NDA that is seeking accelerated approval for selinexor, an oral SINE compound indicated for treating patients with penta-refractory multiple myeloma. The agency has set a user fee review action target date of 4/6/2019. Karyopharm says Selinexor functions by
Drugs
FDA has tentatively approved an Ortho Dermatologics NDA for Bryhali (halobetasol propionate) lotion for the topical treatment of plaque psoriasis in adult patients. In clinical trials, the lotion demonstrated significant treatment success over a vehicle as early as week two, according to the company. “Its safety has been established in
FDA Policy/General
Docket No. Corrected on Dietary Supplement Notice Federal Register notice: FDA corrects the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” 10/05/2018 Info Collection Extension Sought for User Fee Forms Federal Register
FDA Policy/General
Federal Register notice: FDA has announced an 11/14 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting. Panel members are scheduled to discuss a SpecGx NDA for an immediate-release oral tablet formulation of pain drug oxycodone, which is intended to
Drugs
FDA has granted MediciNova an orphan-drug designation for MN-166 (ibudilast) as adjunctive therapy to chemotherapy drug temozolomide for treating glioblastoma. Ibudilast has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS)
FDA Policy/General
Congress failed to secure passage of an FDA spending bill last week and it is looking very likely that the agency’s funding will be covered by a Continuing Resolution (CR) until 12/7, according to an analysis by the Alliance for a Stronger FDA. “Under the CR, FDA is
Devices
FDA has allowed the de novo marketing of Bose Corp.’s Bose Hearing Aid, the first hearing aid that enables users to fit, program and control the device without assistance from a health care provider. The device is intended to amplify sounds for individuals 18 years or older with perceived
Devices
FDA has approved a Zeiss PMA for ReLEx Smile to expand myopia treatment to patients with astigmatism. The approval also provides for a small entry incision to be made, allowing the Smile procedure to be less disruptive to the corneal surface tissue, the company says. The device uses the femtosecond
FDA Policy/General
Federal Register notice: FDA has corrected the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” The corrected docket number is FDA–2018–D–3464. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914” (OMB Control Number 0910–0805). To view the notice, click here.
Drugs
A June FDA inspection of drug supplier McKesson has resulted in a three-item Form 483 citing deficiencies with product tracing requirements. The inspection took issue with the firm’s “deficient” systems to identify all illegitimate product subject to a notification from a trading partner, and to quarantine suspect or
Devices
FDA has cleared an Applied BioCode 510(k) for its BioCode Gastrointestinal Pathogen Panel and its use with the high throughput BioCode MDx-3000 molecular system. The panel tests for 17 most common bacteria, viruses, and parasites that cause infectious diarrhea, according to the company. The clearance is based on
Devices
Washington Legal Foundation (WLF) is asking the Utah Supreme Court to adopt the exception to strict product liability for implanted medical devices that has long applied to prescription drugs. In its amicus brief in a case certified to the state court by the Utah federal court, WLF says that strict
Devices
Adoption of coordinated voluntary disclosure (CVD) policies by medical device manufacturers to promote medical device cybersecurity and patient safety supports public health and safety and also provides manufacturers with a number of legal and non-legal benefits. That’s the conclusion of the Medical Device Innovation Consortium, which includes an
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a draft guidance entitled “Process To Request a Review of FDA’s Decision Not To Issue Certain Export Certificates for Devices.” Comments now should be submitted by 11/15. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Investigational New Drug Application—21 CFR Part 312.” Agency regulations establish reporting requirements that include an initial application as well as amendments to that application, reports on significant revisions of clinical investigation plans, and information on a
FDA Policy/General
Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2019. In addition, FDA has established a docket where interested persons may comment on these guidance priority listings. To access these two lists,
FDA Policy/General
Federal Register notice: FDA has announced a 10/17 regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is intended to provide information and solicit public input
Drugs
Silver Star Brands has recalled six products for humans (including four Native Remedies and two Healthful Naturals and two PetAlive products after testing found microbial contamination. “Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in
Drugs
The New Jersey Supreme Court says 532 product liability claims against Roche alleging that the company inadequately warned of inflammatory bowel disease caused by Accutane should be dismissed. Of the 532 plaintiffs, 18 were New Jersey residents and 514 were residents of 44 other jurisdictions. The claims were designated as
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA complex innovative trial design (CID) pilot meeting program “should help to promote the regulatory acceptance of and agreement on CIDs that support regulatory decision-making across review divisions.” In a comment letter, the association recommends that the agency establish a
Drugs
FDA has cleared an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline) area. In addition, FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. Clearance was based on