FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee 9/7 from 1 p.m. to 4 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee
FDA Policy/General
Federal Register Notice: FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 9/23 entitled, “Pediatric Master Protocols.” Its objective is to discuss regulatory and scientific concerns related to pediatric master protocols and clinical trial design considerations for
FDA Policy/General
Federal Register Notice: FDA will hold meeting 9/15 of the National Mammography Quality Assurance Advisory Committee. It will be held from 8:30 a.m. to 4:30 p.m. at Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy, Gaithersburg, MD. The committee
Biologics
AbbVie has filed suit against Amgen to block its biosimilar version of AbbVie’s blockbuster arthritis therapy Humira. Amgen’s proposed copy would infringe at least 10 patents, AbbVie says in the complaint, which seeks a court order to prevent Amgen from marketing its biosimilar. Last month, an FDA advisory
Drugs
FDA has accepted a Merck NDA for MK-1293, an investigational follow-on biologic copy of Sanofi-Aventis’ Lantus (insulin glargine) for use in treating people with Type 1 and Type 2 diabetes. Because Lantus was not approved under the Public Health Service Act, there is no biosimilar approval pathway
Drugs
Bristol-Myers Squibb (BMS) has reported disappointing data from its CheckMate-026, a trial investigating the use of Opdivo (nivolumab) as monotherapy in advanced non-small cell lung cancer (NSCLC). The trial did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced NSCLC whose
Drugs
Pfizer’s Hospira drug unit has recalled one lot of 0.25% bupivacaine hydrochloride injection, USP (lot # 59-064-DK, expiry 11/1/2017) due to the presence of particulate matter within a single vial, according to an FDA recall notice. The product is indicated for local or regional anesthesia
Devices
FDA is keeping its popular flowcharts in a new draft guidance that updates recommendations on when device makers need to submit a new 510(k) after making device modifications. The guidance has been three years in the making after the agency held a public stakeholder meeting in 2013 on revamping
Devices
Dräger has begun a Class 1 recall of its VentStar Oxylog 3000 Pediatric Patient Breathing Circuit after it was discovered that the check valve on the circuit may leak. “This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels,” a recall
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee have voted 18 to 1 to recommend that an Egalet NDA for Arymo ER (morphine sulfate extended-release tablets) be approved for managing pain severe enough to require daily, around-the-clock,
Devices
FDA is seeking comments on a final set of PMA product codes that have been identified under a two-year retrospective review as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in data collection from premarket to postmarket. Analyzing the Class
Drugs
FDA and Amarin have agreed to amend the company’s special protocol assessment (SPA) agreement for the REDUCE-IT cardiovascular outcomes study involving Vascepa (icosapent ethyl). Currently, the drug is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Earlier
Devices
Four Hogan Lovells attorneys say that the success of a recent FDA draft guidance on using real-world evidence to support regulatory decision-making for medical devices will depend on the agency’s openness to accepting proposed real-world evidence despite its limitations. Writing in an online blog post, the
Drugs
The Biotechnology Innovation Organization (BIO) has published a document with four “considerations” to provide the ethical foundation for any product communication. The group says that the considerations were drawn from application of relevant aspects of BIO’s Statement of Ethical Principles. “In the past,” the document says, “BIO has primarily
FDA Policy/General
Federal Register Notice: FDA has submitted a proposed collection of information entitled, “National Direct-to-Consumer Advertising Survey,” to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The purpose of the survey is to collect updated insights on consumer experiences with
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on a proposed collection of information on “Certification of Identity for Freedom of Information Act and Privacy Act Requests.” Comments should be submitted by 10/3. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Insanitary Conditions at Compounding Facilities. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist state regulatory agencies in understanding some examples
Devices
FDA has cleared an EndoChoice Holdings 510(k) for the Lumos with Adaptive Matrix Imaging, a proprietary imaging software system that is part of the company’s Generation 3 Fuse Full Spectrum Endoscopy System. The software is intended to analyze and selectively enhance the vascularity, surface texture, and color of
FDA Policy/General
Federal Register Notice: FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list includes NuMed, Inc.’s Cheatham Platinum Stent System, Abiomed’s Impella Left Ventricular Support System, and Medtronic Minimed’s iPro2 Continuous Glucose Monitoring System With Enlite Sensor. The agency is informing
Drugs
FDA has denied a 10/17/13 petition from the American Herbal Products Association asking that it (1) formally rescind an agency policy prohibiting investigators from quoting or citing cGMP (current good manufacturing practice) regulations upon which they base inspection findings reported in FDA-483 issued to conventional food and
Drugs
CDER’s Larissa Lapteva says that clinical holds placed on INDs do not lead to “substantial” delays in drug development. Interviewed for a CDER Conversation, she said that the CDER Office of New Drugs’ rare diseases program began collecting data specifically related to rare disease applications in 2010. “At the
Drugs
Sunovion Pharmaceuticals has filed an NDA for SUN-101/eFlow (glycopyrrolate), an investigational treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Glycopyrrolate is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the eFlow nebulizer closed system. The submission is based