Drugs
FDA has released a guidance on “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” The document is intended to assist sponsors interested in submitting an IDE to conduct clinical trials on devices targeting neurological disease progression and clinically meaningful patient centered outcomes.
Drugs
New CDER review documents embedded in a just-released approval package for Sarepta’s controversial Duchenne drug Exondys 51 (eteplirsen) shows how contentious a dispute between director Janet Woodcock and Office of Drug Evaluation 1 director Ellis Unger had become in the final days before Woodcock overrode his decision to
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) have asked the Justice Department and the Federal Trade Commission to investigate potential collusion among pharmaceutical companies that manufacture diabetes products. “The prices of insulin medications, which are used by about 6 million Americans to treat diabetes, have skyrocketed
Devices
CDRH has introduced a new program on the Patient and Care-partner Connection to allow patients and their organizations to dialog with Center staff about specific disease states and medical devices used for their treatment, diagnosis, or assessment. The program addresses one of CDRH’s key strategic priorities −partnering with
Drugs
Lupin says it has resolved GMP deficiencies cited by FDA during an inspection in March at its Goa, India manufacturing plant. The agency issued a nine-item Form-483 related to “inadequacy and adherence to SOPs,” the company said after the inspection. The Goa facility manufactures a range of finished
Drugs
University of Arizona/New York University law school professor Christopher Robertson and Harvard Medical School professor Aaron Kesselheim are urging FDA to stand firm against court decisions on off-label promotion that could lead the agency away from its mission to approve regulated products based solely on scientific evidence. Writing
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) that a Spanish-language video produced by Supernus Pharmaceuticals to influence key opinion leaders about its Oxtellar XR (oxcarbazepine) extended-release tablet for oral use makes false or misleading claims about the drug’s risks and provides evidence that it is intended
FDA Policy/General
The FDA Risk Communication Advisory Committee meets 11/7 to discuss and make recommendations on the agency’s draft Strategic Plan for Risk Communication and Health Literacy, intended to clarify how FDA can communicate the benefits and risks of regulated products to target audiences more effectively and thus promote better
Drugs
Aurinia Pharmaceuticals says it has received positive FDA feedback to plan a single Phase 3 clinical trial for voclosporin and its use in treating lupus nephritis (LN). The encouragement came from the CDER Division of Pulmonary, Allergy and Rheumatology Products during an end-of-Phase 2 meeting, the company says.
Drugs
KemPharm has filed a formal dispute resolution request over a June FDA complete response letter on an NDA for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The complete response letter was in response to an NDA amendment that the
FDA Policy/General
HealthNewsReview.org, which last year began reviewing healthcare PR news releases from a variety of sources on a 10-criteria system, gives a grade of “C” to the five FDA releases it has looked at. The good news for the agency, the report says, is that the releases generally scored
Drugs
Attorney Peter Hawkes (Lane Powell) says the 9th Circuit Court of Appeals has held that Arena Pharmaceuticals’ actions in informing investors about its weight-loss drug lorcaserin gave rise to a strong inference of scienter (legally, intent or knowledge of wrongdoing) since the company knew of FDA’s concerns about
Devices
FDA has cleared a Neural Analytics 510(k) for the Lucid M1 Transcranial Doppler Ultrasound System, a portable device designed for rapid triaging and monitoring of patients with brain disorders. The device is designed to assess brain blood flow from outside the body. It is a battery operated medical grade
Devices
FDA has cleared an Arterys 510(k) for its Arterys Software and its use in clinical settings for the quantification of cardiac flow (4D flow and 2D phase contrast workflows) and cardiac function measurements. Previously, the software was cleared for its 4D Flow visualization feature. The product specifically analyzes blood
FDA Policy/General
Federal Register Notice. FDA has announced the issuance of two emergency use authorizations (EUAs) for in vitro diagnostic devices for detecting the Zika virus in response to the Zika virus outbreak. The EUAs were issued to Vela Diagnostics for its Sentosa test and Arup Laboratories for its Zika Virus Detection
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking an information collection extension on the guidance “Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products.” The document recommends that manufacturers of drug and therapeutic biological products and manufacturers of raw
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a request for OMB to extend an information collection on “The Protection of Human Subjects: Informed Consent; Institutional Review Boards.” The extension request applies to exceptions from informed consent requirements for emergency research, the elements of informed consent, and documentation of
Devices
Spectranetics Corp. has submitted a PMA for the Stellarex drug-coated angioplasty balloon, for use in restoring and maintaining blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. The device, which was first launched in Europe 1/2015, uses EnduraCoat technology, a durable, uniform
Drugs
FDA has issued a guidance, Collection of Race and Ethnicity Data in Clinical Trials, with the agency’s expectations for and recommendations on using a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated products conducted in the U.S. and
FDA Policy/General
Federal Register Notice: FDA has announced a 11/5 Science Board advisory committee meeting at the agency’s White Oak campus (Silver Spring, MD). The board will receive updates on CBER’s strategic goals for regulatory science, FDA’s Opioid Action Plan and the Bovine Heparin Initiative. It will also
FDA Policy/General
Federal Register Notice: FDA has made available a draft revised guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” The document describes the types of fees FDA is authorized to collect under the Animal Drug User Fee Act of 2003, as amended, and how to request waivers and
Drugs
FDA medical reviewers are expressing concern about hepatotoxicity in Cempra’s solithromycin, which goes before the agency’s Antimicrobial Drugs Advisory Committee 11/4 seeking support for an indication to treat community acquired bacterial pneumonia (CABP). A briefing paper released in advance of the meeting says the rates of transaminase