Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has cited a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video montage YouTube video about cholesterol-lowering Livalo (pitavastatin) because it makes false or misleading representations about the drug’s risks. A just-posted OPDP untitled letter says the video “misleadingly
Devices
FDA has approved Abbott’s Proclaim XR recharge-free neurostimulation system for people with chronic pain. The device provides a low dose of Abbott’s proprietary BurstDR stimulation waveform, which was developed based on scientific input to mimic natural patterns found in the brain, according to the company. “It works
Drugs
Federal Register notice: FDA has scheduled a 10/31 public meeting entitled “International Council on Harmonization (ICH) Global Meeting on E8 (R1) Guideline on General Considerations for Clinical Trials.” The meeting is intended to provide information on the increasing diversity of clinical trial designs and data sources being employed to
Devices
FDA has released a suite of guidances “to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.” Principal deputy commissioner Amy Abernathy said in a statement that FDA believes that an appropriate
Drugs
Zogenix has resubmitted an NDA for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome. In April, FDA issued a “refusal to file” letter on the original NDA submission because a preliminary review determined that the NDA was not sufficiently complete to permit a substantive review, the company said
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” Agency regulations require that certain presubmissions and submissions for devices be submitted in electronic format specified by
Drugs
CDER director Janet Woodcock says the reorganization aspect of the Center’s new drugs regulatory program modernization has cleared Congress and the next phase of the plan is being implemented. The intent of the modernization is to streamline resources so that doctors and staff can dedicate more time to drug
Drugs
A 9/27 joint meeting of the FDA Pediatric Advisory Committee and Drug Safety and Risk Management Committee is seeking members’ comments on a pediatric-focused safety review of neuropsychiatric events with the use of montelukast (Merck’s Singulair) asthma and allergy drug. An agency briefing document released in advance
Drugs
FDA has approved a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for treating patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant. Approval was based on data from part one of the Phase 3 CASSIOPEIA study
Drugs
FDA says Apotex is recalling over-the-counter ranitidine tablets (75 mg and 150 mg), a generic form of Novartis’ Zantac labeled by Walgreens, Walmart, and Rite-Aid. An agency statement says the recalled tablets may contain low levels of a nitrosamine impurity, N-nitrosodiemthylamine (NDMA), which is classified as
Drugs
Three Drinker Biddle & Reath attorneys say a 7/9 FDA final guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, demonstrates the importance of classification. Writing online in the National Law Review, the three say that even though the categories lend themselves to a certain level of intuitiveness, “it
Devices
FDA has cleared a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings artificial intelligence to computed tomography (CT). The device helps radiologists interpret images of the thorax (chest) quickly with desired accuracy and precision, and automatically documents these findings
Drugs
FDA has approved an expanded indication for AbbVie’s Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for treating adults and children ages 12 and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection
Devices
CDRH director Jeffrey Shuren has told The MedTech Conference in Boston that FDA may be willing to make public which devices are awarded breakthrough designation. He also said he predicts that the number of breakthrough devices getting final marketing approval will spike in about a year. MedTechDive reports online that
Drugs
A systematic review and meta-analysis conducted by researchers from several locations around the world found that the magnitude of treatment effects was some 2.5-fold higher among treatments that were approved based on non-randomized clinical trials (RCTs) than among treatments that required further testing in RCTs. Writing
Drugs
FDA has renewed the legacy licenses for Certara’s Synchrogenix division’s electronic common technical document (eCTD) review software, GlobalSubmit Review and GlobalSubmit Validate, for another year. The agency has been using the software since 2005. Certara says the licenses provide enterprise-wide use of the GlobalSubmit software for more
FDA Policy/General
Federal Register notice: FDA has determined that Hospira’s atropine sulfate ansyr plastic syringe (atropine sulfate solution) intravenous, intramuscular, subcutaneous, and endotracheal, 0.5mg/5 mL, was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Med-El Electromedizinische Gerate’s medical device Med–El EAS, intended to provide electrical stimulation to the mid- to high-frequency region of the cochlea and acoustic amplification to the low-frequency regions, for candidates
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Human Tissue Intended for Transplantation — 21 CFR Part 1270” (OMB Control Number 0910-0302). FDA’s regulations provide for FDA inspections of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of
Devices
FDA has published a draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, to meet an FDA Reauthorization Act requirement that it issue by 10/1 a draft guidance providing for further standards for the
FDA Policy/General
House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017 had not delayed reviewing e-cigarettes that are on the market. In exercising its enforcement discretion, FDA has given e-cigarette makers until 5/2020 to submit
Drugs
FDA has granted breakthrough therapy designation for Achillion Pharmaceuticals’ danicopan for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria who are sub-optimal responders to a C5 inhibitor alone. The agency’s decision reportedly was based on positive safety and efficacy data from an