FDA Policy/General
A Vanda Pharmaceuticals Web page for Fanapt (iloperidone) tablets for oral use and Hetlioz (tasimelteon) capsules for oral use presents information about the two drugs but fails to include any risk information about either one, according to a 10/22 Warning Letter issued by CDER’s Office of Prescription Drug
Drugs
FDA has approved Merck’s Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer. Approval was based on data from the KEYNOTE-407 trial, which showed that Keytruda’s combination use with chemotherapy
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Development of Dried Plasma Products Intended for Transfusion.” The document provides recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions. To view the
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 10 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested each approval be withdrawn. To view the notice, click here.
Devices
FDA has posted details of an “Accreditation Scheme for Conformity Assessment (ASCA)” pilot program that “aims to enhance the predictability of the medical device review process by reducing premarket questions in areas where current conformity activities result in inconsistent testing practices, conformance declarations, and regulatory review.” ASCA seeks to increase
Drugs
FDA staff in the Office of Generic Drugs and Office of Biostatistics say their review of data collected in the third and fourth calendar years of GDUFA 1 shows a trend toward increased first-cycle approval of ANDAs. Writing in Therapeutic Innovation & Regulatory Science, the FDAers say the rate
Drugs
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meet 11/1 to consider issues involved in the CDER review of an Alkermes NDA for a combination product containing buprenorphine and samidorphan intended to be used as an adjunct to established antidepressant pharmacotherapy
FDA Policy/General
FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram say the agency is taking new steps to put in place modern regulations that foster innovation in plant and animal biotechnology through a new Plant and Animal Biotechnology Innovation Action Plan. “This new plan advances policy priorities that FDA will pursue
Drugs
FDA has alerted health care professionals and patients about two-month expiry date extensions on some epinephrine auto-injectors, .15 mg and 0.30 mg, distributed by Impax Generics. The extensions were granted due to intermittent supply interruptions involving the products. “To help ensure patient safety, these products should have
FDA Policy/General
Federal Register notice: FDA has opened a public docket to receive suggestions and comments on the agency’s publication of its surrogate endpoint table (SE table). FDA has developed a Web page that displays the SE table, describes the purpose of the table, and provides additional background information. Comments received
FDA Policy/General
Federal Register notice: FDA’s chief scientist has denied a request for a hearing on a CDER proposal to refuse approval of a Pharmaceutical Manufacturing Research Services (PMRS) NDA for oxycodone hydrochloride immediate-release oral capsules. The notice summarizes the grounds for not approving the submission. On 11/16/2017,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Boule Medical Stockholm, Sweden (10/2): FDA inspected the firm and cited GMP deficiencies with its Medonic M-Series Hematology Analyzer. For example, the firm failed to establish and
Devices
A 3/19-3/22 FDA inspection at Leventon S.A.U., Barcelona, Spain, found Quality System Regulation violations in the firm’s manufacturing of the Dosi Flow elastomeric infusion pump and Dosi Flow administrative set. A 9/5 Warning Letter says that specific violations listed on an FDA-483
Drugs
Three medical school professors have petitioned FDA to require addition of Warnings, Precautions, a Boxed Warning, and other language to the labeling for all isotretinoin products to inform users of sexual side effects. The 10/26 petition asks for the immediate revision of all isotretinoin labels to: * add Warnings, Precautions,
FDA Policy/General
Federal Register notice: FDA has announced a12/4-5 Circulatory System Devices Panel of the Medical Devices Advisory Committee. On 12/4, the committee will discuss, make recommendations, and vote on an Impulse Dynamics PMA for the Optimizer Smart Implantable Pulse Generator, indicated to provide cardiac contractility modulation for Class
Drugs
Abbott Laboratories and its spin-off AbbVie have agreed to pay $25 million to resolve allegations that they used kickbacks and off-label marketing and promotion efforts to induce physicians to prescribe cholesterol drug TriCor (fenofibrate tablets). According to the Justice Department, between 2006 and 2008 Abbott knowingly paid kickbacks
Drugs
FDA inspected a Minnesota medical center and found violations that “subjected unwitting patients to dangerous and unethical human testing,” according to documents obtained by Public Citizen under the Freedom of Information Act (FOIA). Researchers at Hennepin County Medical Center “failed to obtain consent from test subjects for high-risk clinical
Drugs
FDA has approved a Jazz Pharmaceuticals supplemental NDA to revise labeling for Xyrem (sodium oxybate) oral solution to include an indication to treat cataplexy or excessive daytime sleepiness in patients with narcolepsy ages seven and older. Approval was based on data from the multisite Phase 2/3 EXPRESS study, which
FDA Policy/General
Federal Register notice: FDA has classified the active implantable bone conduction hearing system into Class 2 (special controls). FDA’s action was based on a 2/2017 MED–EL Elektromedizinische Geraete request for de novo classification of the BoneBridge, which is identified as a prescription device consisting of an implanted
FDA Policy/General
Federal Register notice: FDA has classified high-flow humidified oxygen delivery devices into Class 2 (special controls). FDA’s action is based on a 1/2017 Vapotherm de novo classification request for its Precision Flow HVNI, which is identified as a prescription device that delivers high flow oxygen with humidification
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Novo Nordisk’s Rebinyn (coagulation factor IX recombinant) glycopegylated), indicated for use in adults and children with hemophilia B. The regulatory review period has been determined to be 2,793 days, which includes 2,
Devices
FDA has cleared an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class 2 teeth alignment correction in tween and teen patients. The device is designed to move the lower jaw forward while simultaneously aligning the teeth. It is intended to replicate