Drugs
The Justice Department says that Mylan has agreed to pay $465 million to resolve False Claims Act allegations that it knowingly misclassified EpiPen as a generic drug to avoid paying rebates owed primarily to Medicaid. A department news release says Sanofi-Aventis filed a whistleblower suit alleging the EpiPen misclassification
Devices
FDA says it is making available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. The panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses. An agency news statement says that
Drugs
CNBC profiles several firms that are developing human organs on chips — miniaturized versions of livers, lungs, kidneys, intestines, and others that “may offer a less time-consuming and costly way to test drugs, foods, cosmetics, and dietary supplements for efficacy and toxicity, with the goal of vastly improving upon traditional
FDA Policy/General
Federal Register notice: Responding to a citizen petition request, FDA has determined that Wyeth Pharmaceuticals’ Cordarone (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency can approve ANDAs that refer to the product as long as they
FDA Policy/General
Federal Register notice: FDA has a announced a 9/14 joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. Panel member are scheduled to review a Purdue Pharma supplemental NDA new for Butrans (buprenorphine) transdermal system for use in pediatric
Drugs
A survey of 83 clinical studies supporting 78 PMA panel-track supplements approved by FDA between 4/19/06 and 10/9/15 found that only 45% were randomized clinical trials and 30% were blinded. Researchers writing in the Journal of the American Medical Association say that of the 150
Drugs
Two Parexel executives write in a Life Science Leader online post that drug developers could make NDA/BLA development meetings with FDA staff more productive by adopting a framework for the discussion that helps them consider the advantages and disadvantages of every option, both with and without FDA advice. The
Devices
Writers of a Health Affairs blog post say FDA’s new approach to digital health — shifting from premarket to postmarket review by FDA and shifting from FDA oversight to oversight by independent, non-government certifiers — raises as many questions as it answers. The post says that the 21st Century Cures
Devices
FDA has cleared a Stryker 510(k) for the Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System. The device features serrated cutting flutes, a dual-thread pattern with an increased number of leads for rapid insertion, and
Biologics
FDA has accepted for priority review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) for use in patients with cutaneous T-cell lymphoma. The submission is based on data from the Phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials. The agency has set a user fee
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports substantive research focused on prescription drug advertising and promotion, but is concerned with FDA’s recent approaches to studies in this area. In a letter commenting on an agency proposal to study disclosures in professional and consumer prescription drug promotion,
Drugs
Amneal Pharmaceuticals has recalled 13 lots of lorazepam oral concentrate, USP 2mg/mL, due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a third party-manufactured dosing dropper has been found in some instances to have printed dose markings in
Drugs
Federal Register notice: FDA has withdrawn the approval of an Upsher-Smith Laboratories ANDA for zaleplon (reference product: Sonata) capsules, 5 mg and 10 mg. The company requested the withdrawal after being contacted by FDA about concerns with the validity of bioequivalence data from studies conducted by an unnamed contract
Devices
Cook Medical has recalled its Zenith Alpha Thoracic Endovascular Graft when used for treating blunt traumatic aortic injury (BTAI) because blood clots may form inside the device after implantation. “Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI,
Drugs
Former FDA commissioner Robert Califf says a sweeping overhaul of the current clinical trial system is needed and underway. Writing in the Journal of the American Medical Association, Califf acknowledges complaints that the current system moves too slowly to approve new drugs or rushes new drugs to market without adequate
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Foshan Flying Medical Products Co. Foshan City, China (8/1): FDA inspected the firm in February and cited significant GMP violations with its finished pharmaceuticals. For example, the firm
Devices
FDA has approved a Vascular Dynamics IDE application to start a pivotal CALM 2 (Controlling and Lowering Blood Pressure with MobiusHD) trial of its Mobius system for treating resistant hypertension. The trial will evaluate patients from multiple U.S. sites whose hypertension remains uncontrolled despite three or more antihypertensive pharmacologic
Devices
FDA has cleared a BioStable Science & Engineering 510(k) for the HAART 200 Aortic Annuloplasty Device, an annuloplasty device designed specifically for bicuspid aortic valve repair. The device is designed to facilitate valve repair in patients with aortic valve insufficiency. It is intended to reduce annular diameter based upon
Drugs
FDA has posted a transcript of a 7/19 public meeting on Hatch-Waxman Amendments and its discussion on whether an appropriate balance is still maintained between brand and generic companies since the law was enacted in 1984. At the meeting, FDA commissioner Scott Gottlieb outlined new approaches the agency
Drugs
FDA has accepted for review a Portola Pharmaceuticals BLA resubmission for AndexXa (andexanet alfa) and its use as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery.
Drugs
A 2/20-23/17 FDA inspection at Foshan Flying Medical Products, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/1 Warning Letter. Specific violations cited were: * failing to establish an adequate quality control unit and procedures applicable
Drugs
A 1/9-1/13 FDA inspection at Homeolab USA, Montreal, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/2 Warning Letter. Specific violations cited in the letter were: * failing to establish and follow adequate control procedures to monitor the