FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Lernapharm (Loris) Inc. Montreal, Canada (9/4): FDA inspected the firm 12/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish and
FDA Policy/General
Federal Register notice: FDA has made available for public comment of a revised draft document (XXX INSERT, DELETE XXX)“Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration.” The revision (XXX SUBSTITUTE, DELETE XXX)describes
FDA Policy/General
Federal Register notice: FDA has announced a 11/27 public meeting entitled “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.” After receiving input from stakeholders, the agency intends to provide a report to Congress about the root causes and recommendations regarding new authorities FDA or other agencies
FDA Policy/General
Trump Administration senior associate counsel to the president Stacy Cline Amin is moving to FDA to serve as chief counsel. Prior to her administration post, Amin served as chief counsel to the U.S. Senate Committee on Health, Education, Labor and Pensions, and before that as counsel to the U.
Devices
After years of FDA resistance, CDRH officials have agreed to meet 9/13 with injured LASIK patients seeking an agency ban on the vision-correction indication for the ophthalmic lasers used in the procedure. The group is being led by former CDRH branch chief Morris Waxler, who approved the LASIK
FDA Policy/General
Federal Register notice: FDA has announced a 10/18 Gastrointestinal Drugs Advisory Committee meeting. Panel members are scheduled to review a Shire NDA for prucalopride tablets, indicated for treating chronic idiopathic constipation in adults. To view the notice, click here.
Drugs
FDA has posted a draft guidance entitled “Postapproval Changes to Drug Substances.” The document applies to synthetic drug substances and the synthetic steps involved in preparing semi-synthetic drug substances. It covers facility, scale, and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials,
FDA Policy/General
Federal Register notice: FDA has determined that Corden Pharma Latina’s Cefzil (cefprozil) tablets, 250mg and 500mg mg, and Cefzil for oral suspension,125mg/5mL and 250mg/5mL were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to continue to approve ANDAs that
Drugs
FDA has approved a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. The approval provides a new dosage strength (16mg/4mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and
Biologics
FDA has issued GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts. The letter states that more clinical data are required
Devices
FDA has cleared a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and neonatal patients. Previously, RAM was cleared to monitor adult and pediatric patients greater than 10 kg using RAS-125c and RAS-45 sensors. “With clearance of
Drugs
Members Sought for Mammography Quality Panel Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. 09/07/2018 Guide on Dietary Supplement Microbial Labeling Federal Register notice: FDA makes available a draft guidance entitled “Policy Regarding Quantitative Labeling of
FDA Policy/General
Johnson & Johnson Medical has agreed to acquire German software company Surgical Process Institute, a firm focused on standardizing and digitalizing surgical workflows in operating rooms. Surgical Process provides software solutions designed to improve patient outcomes and operating room efficiency by reducing variability in surgical procedures. Financial terms of the
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. To view the notice, click here.
Biologics
FDA has extended by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, and paclitaxel in first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC). The extension was granted to allow the agency to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” The draft advises dietary supplement firms of FDA’s intent to exercise enforcement discretion if a firm wishes to specify the amount of a live microbial in colony forming
Drugs
FDA has approved labeling revisions for three HIV drugs to include information on the risk of neural tube defects. The changes apply to ViiV’s Tivicay (dolutegravir), Triumeq (abacacir, dolutegravir, and lamivudine), and Juluca (dolutegravir, rilpivirine). In addition, weight gain was added to the Postmarketing Experience subsection of each label.
Drugs
A California federal court has dismissed on procedural grounds a suit brought by Pharmaceutical Research and Manufacturers of America (PhRMA) seeking to block enforcement of California Senate Bill 17 that imposed notification and reporting requirements on drug manufacturers for certain price increases on their products sold to state purchasers, insurers,
Devices
FDA has cleared a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of bioabsorbable technologies for reconstructive and cosmetic surgery. “Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing
Drugs
FDA has denied, as “not appropriate at this time,” an International Probiotics Association 11/1/16 petition asking the agency to require that the quantitative amount of probiotic ingredients be declared in terms of colony forming units (CFUs). The denial letter notes issuance of a draft guidance explaining FDA’s
Drugs
FDA commissioner Scott Gottlieb says that as part of efforts under its 2018 Compounding Policy Priorities Plan, it has revised a draft memorandum of understanding (MOU) between FDA and states. He says the revised MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions. “Today’s
Drugs
FDA has scheduled a 10/19 public meeting on “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC). A notice says the session is intended to provide members of the pharmaceutical industry and interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues