Devices
FDA has issued a training video to help mammography facilities and their staffs better understand new Mammography Quality Standards Act inspection review questions dealing with mammography image quality. CDRH Division of Mammography Quality Standards director Helen Barr says in her introduction to the video’s mock inspection scenario that image
Drugs
An online National Law Journal post says that a January FDA draft guidance on considerations in demonstrating interchangeability with a reference product outlines the nature and quality of the evidence biosimilar applicants should expect the agency to demand before making a finding of interchangeability for a biosimilar. “Because of the
Drugs
FDA has approved two Upsher-Smith Laboratories supplemental NDAs for Qudexy XR (topiramate) Extended-Release Capsules for use in preventing migraine headache in adults and adolescents 12 years of age and older. Topiramate is the active ingredient in Janssen Pharmaceuticals’ Topamax (topiramate) and is the molecule that neurologists prescribe most
Devices
FDA has cleared a RenovoRx 510(k) for its RenovoCath adjustable dual-balloon infusion catheter to include “delivery of chemotherapeutics.” The device isolates segments of the peripheral vasculature, allowing physicians to deliver therapeutic agents in a more targeted approach. “Studies show that the targeted delivery of chemotherapy may allow for
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that its members believe that additional dialog between FDA and industry is needed to resolve several fundamental issues before an agency draft guidance on submission of quality metrics data can move forward. “PhRMA respectfully requests that FDA pause its efforts to implement
Devices
CDRH has released a statement of what it accomplished in 2016 toward three 2016-17 strategic priorities — establishing a national evaluation system for medical devices, partnering with patients, and promoting a culture of quality and organizational excellence. The document shows supporting actions the Center took for each of the priorities
Drugs
An FDA-483 issued at the conclusion of a 3/2-3/10 agency inspection at Alkem Laboratories, Pradesh, India, lists these observations: * failing to follow the written testing stability program; * master production and control records lack complete manufacturing and control instructions and special notations; and * failing to have written
Drugs
A Dr. Reddy’s oncology drug formulation manufacturing facility at Duvvada, Visakhapatnam, India, that was one of the facilities named in a 2015 Warning Letter, has been issued a 13-item Form-483. The February inspection cited the firm for failing to thoroughly review any unexplained discrepancy whether or not
Drugs
FDA has approved a Genentech NDA for Ocrevus (ocrelizumab) for treating adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Approval for the intravenous infusion was based on data from two clinical trials in 1,656 participants treated for 96 weeks, according to an
Drugs
The Arizona legislature has approved the Free Speech in Medicine Act that authorizes drug and medical device companies to communicate truthful off-label treatment information to medical professionals. The bill was supported by the Goldwater Institute, which also has promoted state and federal “right-to-try” legislation. The institute reports
FDA Policy/General
FDA commissioner nominee Scott Gottlieb has detailed how he will divest the many financial interests he has in health-related companies, and has promised to recuse himself from agency decisions involving those companies for one year after his confirmation. The information is included in a 3/29 eight-page letter
Drugs
FDA has issued Mylan a complete response letter on its ANDA for a generic copy of GlaxoSmithKline’s asthma therapy Advair Diskus (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder). Without providing any specifics on FDA’s concerns with the submission, Mylan said it is in the process
Devices
FDA has cleared a NuVasive 510(k) for the CoRoent Small Interbody System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. The interbody cage is manufactured from polyether ether ketone-Optima that is intended to provide stabilization of the spinal motion segment while fusion takes
Drugs
The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb and the Cancer Research Institute (CRI) have announced a multi-year clinical research collaboration to coordinate and begin clinical immuno-oncology studies across the Parker Institute and CRI networks. Under the agreement, Bristol-Myers Squibb will work closely with Parker Institute
Devices
FDA has cleared a Bodycad 510(k) for its Bodycad Unicompartmental Knee System, a joint reconstruction implant system. The device is designed to “optimize personalized restoration of the patient's unique anatomical features and kinematics,” the company says. “The system is based on proprietary 3D rendering of medical images
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted unanimously (11 to 0) that the benefit-risk ratio of rituximab/hyaluronidase for subcutaneous injection was favorable for treating certain blood cancers, which include: previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma, relapsed or refractory low grade or follicular
Drugs
Sen. Claire McCaskill (D-MO), ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, has asked Purdue, Janssen/Johnson & Johnson, Insys, Mylan, and Depomed for documents and records from the last five years indicating what the companies knew about risk for abuse of opioids and their marketing
Drugs
Purdue Pharma is asking FDA to ensure that follow-on products citing its Butrans (buprenorphine) transdermal system for transdermal administration as the reference-listed drug are as safe and effective as Butrans. The company’s petition specifically asks the agency to: * require that applications referencing Butrans contain appropriate toxicology and
Drugs
Attorney Kurt Karst says that an apparent settlement between FDA and Ferring Pharmaceuticals over five-year new chemical entity (NCE) exclusivity for Ferring’s colonoscopy prep Prepopik (sodium picosulfate, magnesium oxide, and citric acid) for oral solution is likely to cause problems for the agency’s Office of Generic Drugs
Drugs
FDA associate commissioner for international programs Mary Lou Valdez says that regulators and drug companies in India recognize that a quality culture is imperative if the country is to increase productivity, reduce compliance risk, lessen rework, and minimize supply interruptions that result in lost revenue and increased risks to public
Devices
Researchers at the Massachusetts Institute of Technology and Boston Children’s Hospital say they have identified a signaling molecule that is key to the process of “fibrosis” in which medical devices implanted in a body for drug delivery, sensing, or tissue regeneration become surrounded by a wall of dense scar
Drugs
FDA has approved a Regeneron Pharmaceuticals NDA for Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema. The drug is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable, an agency release says. Injected under the