FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. The proposed framework would provide prescription drug sponsors the flexibility to develop and disseminate innovative software,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Contract Systems Bloomington, MN (11/6): FDA inspected the firm’s medical device operations in October and cited GMP deficiencies. For example, the firm failed to adequately validate
Devices
In a joint statement, FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say they have a new medical device safety goal: to ensure that FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. Their statement also discusses
Drugs
FDA has posted online questions and answers about impurities found in certain generic angiotensin II receptor blocker products. Beginning in June, the agency says, it found that some generic versions of the prescription drug valsartan contained unexpected impurities that posed a safety concern. The document says the impurities, N-Nitrosodimethylamine
Drugs
FDA has approved Novimmune’s Gamifant (emapalumab) for treating pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional therapy. HLH is a condition in which the body’s immune cells do not work properly, according to an FDA release.
FDA Policy/General
Truth in Advertising, a non-profit consumer watchdog, says that some of the country’s biggest and most prestigious cancer treatment centers use misleading testimonials that fail to disclose that their results are not typical. NBC News reports that Truth in Advertising found that out of 48 cancer centers, 90%
Drugs
FDA has issued Warning Letters to two companies it says are illegally marketing products labeled as dietary supplements that contain tianeptine, a chemical compound that companies illegally claim treats opioid use disorder, pain and anxiety, and other claims the agency says are unproven and unlawful. “These actions follow reports to
Devices
FDA says a Beckman Coulter recall of its FC 500 and EPICS XL series flow cytometers is Class 1. An agency recall notice says the devices are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. They can be used to
Devices
FDA has cleared a SIG Medical 510(k) for its AdvantageRib Anterior System, intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone. The device contains titanium plates and screws to treat rib fractures through a traditional anterior approach, according to the company.
FDA Policy/General
Federal Register notice: FDA has determined that 47 drug products it is listing were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will not begin procedures to withdraw approval of ANDAs that reference the drug products, and it will allow FDA to
Drugs
FDA and Duke-Margolis Health Policy Center have planned an 11/27 public meeting to seek stakeholder input on long-term solutions to address the drug shortage problem and identifying potential ways to implement the solutions. The meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions, is
Drugs
FDA has approved an expanded label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST). The oral thrombopoietin receptor agonist is currently approved for SAA for patients who have
Drugs
FDA is alerting health care professionals and patients not to use drug products produced and distributed by Pharm D Solutions (Houston, TX) due to lack of sterility assurance. FDA says it sent the firm a Warning Letter 12/2016, and a recent follow-up inspection in August cited insanitary conditions,
FDA Policy/General
FDA 11/19 responded to a petition to allow a new qualified health claim for edible oils containing high levels of oleic acid, a monounsaturated fat that has cardiovascular benefits when it replaces heart-damaging saturated fat. Product labeling for the oils can state: “supportive but not conclusive scientific evidence
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications” (OMB Control Number 0910-0719), To view the notice, click here.
Drugs
FDA has issued Aquestive Therapeutics a complete response letter (CRL) on its 505 (B)(2) NDA tadalafil oral film, a PDE5 inhibitor currently marketed (Eli Lilly’s Cialis) in tablet form for treating erectile dysfunction and benign prostatic hyperplasia, and for treating pulmonary arterial hypertension (Lilly’s Adcirca). The letter
Drugs
FDA is seeking input on how it can promote the development of digital technologies that would guide safe and effective prescription drug use to help patients improve their health. “As part of this process, we’re seeking input from the public on new steps to modernize our approach to overseeing
FDA Policy/General
Annual Report on Post Marketing Requirements/Commitments Federal Register notice: FDA announces the availability of its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” 11/16/2018 Consumer Reps Needed for Advisory Committees Federal Register notice: FDA seeks consumer organizations
Drugs
AstraZeneca and MedImmune say results from their Phase 3 MYSTIC trial involving Imfinzi (durvalumab) did not meet primary endpoints of improving overall survival compared to standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The randomized, open-label,
FDA Policy/General
Senator Mike Enzi (R-WY) has written FDA commissioner Scott Gottlieb expressing concern over eventual senior staff turnover and asking for details of the agency’s succession plan. In the 11/14 letter, Enzi asked for details on how the agency is working to “ensure a strong pipeline of leadership
Drugs
In less than two weeks after submitting a supplemental BLA, FDA approved a Seattle Genetics submission for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (see earlier story). The agency says it reviewed the sBLA under its Real-Time
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) has petitioned FDA asking it to not approve any opioid product seeking an indication or any other labeling that suggests it is appropriate for chronic use. Specifically, the petition cited SpecGx’s MNK-812 (oxycodone), with relies on Roxicodone as the reference listed drug (see