FDA Policy/General
BIOLOGICS FDA has approved Bayer’s Kovaltry (antihemophilic factor-recombinant), a factor VIII compound for treating hemophilia A in children and adults. The approval is based on data from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which demonstrated the therapy’s supported
FDA Policy/General
BIOLOGICS Guidance on Biologics License Provisions Federal Register Notice: FDA is making available a draft guidance for industry entitled Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009. It describes the agency’s approach to implementing the statutory provision under
Drugs
CorMatrix Cardiovascular has begun a feasibility study involving its tissue-engineered regenerative CorMatrix ECM Tricuspid Valve. The study at eight sites in the U.S. is intended to demonstrate proof of principle and initial clinical safety of the valve for the surgical management of tricuspid valve disease not amenable to
Drugs
The Generic Pharmaceutical Association (GPhA) has urged the Senate to put an end to restricted distribution agreements that delay generic drug competition. The group’s call to end such practices comes as the Senate Aging Committee discusses anti-competitive business practices used by brand manufacturers to stifle generic competition. “FDA-
Drugs
FDA has issued Eagle Pharmaceuticals a complete response letter on a 505(b)(2) NDA for Kangio (bivalirudin injection), a ready-to-use intravenous formulation for use as an anticoagulant. The agency letter requested further characterization of bivalirudin-related substances in the drug product. Eagle will work directly with the
Devices
Verathon has begun a Class 1 recall of its GlideScope Titanium Single-Use Video Laryngoscope due to potential video feed disruptions. The device is used to obtain a clear view of the vocal cords and to assist in inserting a tracheal tube used during other medical procedures (general anesthesia). A
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Quantitative Information in Direct-to-Consumer Television Advertisements,” 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.
FDA Policy/General
Federal Register Notice: FDA seeks comment on “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” Comments should be submitted by 5/17. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Wesley A. McQuerry from providing services in any capacity to a person that has an approved or pending drug product application. McQuerry was convicted of a felony under federal law for conduct
Devices
FDA’s Circulatory System Devices Panel has voted unanimously to not recommend approval of an AngelMed PMA for its Guardian System to warn about electrocardiogram elevation changes in the segment between the S wave and the T wave, which potentially is linked to coronary ischemia. Panel members cited protocol deviations
Drugs
FDA and the National Institutes of Health (NIH) are developing a template with instructional and sample text for NIH-funded investigators to use when writing protocols for Phase 2 or 3 clinical trials that require IND or IDE submissions. Their goal is to make it easier for investigators to prepare
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications. In order to improve the process for submission and CMC information for animal drugs, CVM has developed a series of questions that
FDA Policy/General
FDA’s Office of New Drugs (OND) has granted a Fabre-Kramer Pharmaceuticals appeal through the agency’s formal dispute resolution process and has concluded that its Travivo (gepirone) demonstrates substantial evidence of effectiveness in treating major depressive disorder, thereby overturning the agency’s previous position reached at a lower
Drugs
FDA has approved Bayer’s Kovaltry (antihemophilic factor-recombinant), a factor VIII compound for treating hemophilia A in children and adults. The approval is based on data from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which demonstrated the therapy’s supported safety
Devices
FDA has cleared a CardiacAssist 510(k) for its TandemLung oxygenator, a device that acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood. It uses a radial flow design coupled with advanced polymethylpentene fibers to transfer oxygen into the blood for patients requiring cardiac
Devices
FDA has classified as Class 1 a recall by Arrow International of its intra-aortic balloon catheter kits and percutaneous insertion kits due to a sheath separation issue. If the separation occurs, the patient may bleed from the sheath. Interruption or loss of intra-aortic balloon pump treatment may also
Drugs
Research reported in the April issue of Medical Care shows that among older adults with diabetes, white patients and those with lower incomes were moderately slower in discontinuing Avandia (rosiglitzane) after an FDA safety alert was issued. “This work speaks to the efficacy and equity of FDA safety advisories across
Devices
FDA has cleared a PneumaCare 510(k) for its Thora-3DI imaging device, intended for use in measuring breathing. The device uses structured light plethysmography to measure breathing by detecting movement in the chest and abdomen. It can be used to measure respiratory status in patients with a range of
Drugs
A new ProPublica analysis finds that doctors who receive payments from industry tend to prescribe more brand-name medications than their colleagues who don’t. ProPublica says its analysis doesn’t prove industry payments sway doctors to prescribe particular drugs, or even a particular company’s drugs. “Rather, it shows
Drugs
FDA has accepted for priority review an Elite Pharmaceuticals NDA for SequestOX (oxycodone hydrochloride and naltrexone), an opioid abuse-deterrent candidate for managing moderate to severe pain where the use of an opioid analgesic is appropriate. The agency has set a 7/14 user fee review target date. The company
Drugs
The Bass Berry & Sims 2015 Healthcare Fraud and Abuse Review says that only a fraction of the $3.6 billion in Fiscal Year 2015 civil fraud recoveries involved matters concerning the drug industry, while a significant amount of them involved whistleblower actions raising issues of medical necessity and improper
FDA Policy/General
Federal Register Notice: CBER and CDER are announcing the end of support for Version 1.0 of Clinical Data Interchange Standards Consortium Case Report Tabulation Data Definition Specification (Define.xml) and an update to the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which has been available