Devices
FDA has added new information to the labeling of warfarin international normalized ratio (INR) test meters for patients, caregivers and health care providers using the devices at home or in a clinical setting. The agency says it has received Medical Device Reporting-related adverse events about meters which may have
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Symdeko (tezacaftor/ivacaftor) for treating the underlying cause of cystic fibrosis in patients aged 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or who have at least one mutation that is
FDA Policy/General
FDA stands to gain a $663 million (13%) budget boost in President Trump’s just-released fiscal year (FY) 2019 budget proposal, treatment not afforded most other non-military programs, which face massive cuts in the unlikely event that Congress agrees to all of those reductions. The budget includes $5.
FDA Policy/General
FDA commissioner Scott Gottlieb is getting mostly high marks from agency watchers, unlike many in Trump Administration top posts that have found themselves embroiled in controversy after controversy, according to a New York Times article. “Now, more than nine months after he was confirmed, Dr. Gottlieb has achieved something unusual
Drugs
FDA has released a guidance on Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment that is intended to assist sponsors with pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. These issues were discussed at an FDA/American
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension request for “Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling” (OMB Control Number 0910-0624). To view the notice, click here.
FDA Policy/General
Federal Register notice: CDER has announced a continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program. Pharmaceutical companies are invited to participate in the program, and those interested should send proposed agendas to the agency by 4/13. To view the notice, click here.
FDA Policy/General
Information Collection Extension for CVM Dispute Resolution Federal Register notice: FDA submits for OMB approval an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine.” 02/09/2018 Information Collection Extension for ADR eSubmission Waivers Federal Register notice: FDA
Drugs
A Washington Legal Foundation brief has urged U.S. Court of Appeals for the Seventh Circuit to reject a “novel theory of liability” that would hold pharmaceutical manufacturers liable for injuries caused by drugs they did not manufacture. In Dolin v. GlaxoSmithKline, Wendy Dolin alleges that her husband’s 2010
Drugs
CDER has launched a new External Stakeholder Meeting Request system for requesting meetings with Center officials on drug development and drug safety matters. “Meetings with patient advocacy groups, health care professionals, and other non-industry stakeholders are invaluable to our work,” the agency says. “They provide a mechanism for communicating
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine — 21 CFR 10.75” (OMB Control Number 0910-0566). To view the notice, click here.
Drugs
FDA has extended by three months the user fee review of Salix Pharmaceuticals’ NDA for Plenvu (NER1006). The new review target date is 5/13, and it gives agency reviewers more time to review additional data that were recently provided at FDA’s request. Plenvu is an investigational, novel, low-
Drugs
FDA has granted Xeris Pharmaceuticals an orphan drug designation for its ready-to-use, liquid-stable glucagon for treating hyperinsulinemic hypoglycemia, a condition in which blood glucose levels become low due to excessive insulin secretion. The designation was granted, in part, on the basis that mini-doses of glucagon may
Devices
Philips Electronics has recalled its HeartStart MRx Defibrillator due to a defect in the device’s gas discharge tube. The tube has micro cracks which allow internal gasses to escape and cause the tubes to not function as expected, an FDA notice says. “This also permits an electrical current surge
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension request for “Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements” (OMB Control Number 0910-0770). To view the notice, click here.
Drugs
A new report on cutting drug prices from the White House’s Council of Economic Advisers has recommended innovation cost reductions through FDA reforms, among other suggestions. Because it takes 10 years and $2.6 billion to develop a drug and reach approval, reforms that significantly reduce the fixed costs
Drugs
FDA says it and the Nuclear Regulatory Commission (NRC) have taken steps to ensure a stable and secure supply of Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. An FDA news release says the agency approved NorthStar Medical Radioisotope’s RadioGenix System, a unique system for
Drugs
FDA has issued 57 new and updated product-specific guidances intended to help the generic drug industry identify the most appropriate methodology for generating evidence needed to support approval of generic drug applications. The online document says generic drug applicants should consider that their product is expected to be pharmaceutically
Drugs
Five days after FDA denied without comment United Therapeutics’ fourth Tyvaso (treprostinil) inhalation solution ANDA petition, the company has submitted a fifth petition, that it says is substantively the same as the previous four. In each petition, the company asks that FDA not approve any ANDA for a treprostinil inhalation
Drugs
FDA has issued Sandoz a complete response letter, denying approval for its proposed generic copy of GlaxoSmithKline’s Advair Diskus (fluticasone propionate/salmeterol). The product is indicated for treating asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in
Drugs
FDA has approved a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis. Expanded approval was based on data from a Phase 3 trial in scalp psoriasis patients where Cosentyx demonstrated superior efficacy compared to placebo, the company says. The human interleukin-
Devices
FDA has cleared a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the company’s polymerase chain reaction testing platform, which is designed for point-of-care infectious disease diagnosis. The test provides a qualitative result in about 30 minutes. It is indicated