FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Data Integrity and Compliance With CGMP. It purpose is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs and is in response to an increase in CGMP violations involving data integrity
FDA Policy/General
Federal Register Notice: FDA’s Antimicrobial Drugs Advisory Committee will meet 6/9, from 8:30 a.m. to 5 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 will discuss a Merck BLA
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee 6/2-3, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss recent
FDA Policy/General
Federal Register Notice: FDA is correcting a 3/10/14 Federal Register notice that withdrew approval of 8 NDAs and 46 ANDAs for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of an Xanodyne Pharmaceuticals NDA 017507 for Darvocet-N 100 (propoxyphene napsylate and
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Cyramza (ramucirumab) is 3,521 days for extending a patent which claims the human biological product. Cyramza is indicated for treating gastric cancer. To view this notice, click here.
FDA Policy/General
FDA has granted approval to Redwood City, CA-based Nevro Corp. for surgical leads that are specifically designed for use with the Senza Spinal Cord Stimulation (SCS) System delivering HF10 therapy for chronic leg and back pain. The company says its HF10 therapy delivers electrical pulses to the spinal cord
FDA Policy/General
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support ANDAs. These products include: albendazole, amlodipine besylate, betamethasone dipropionate, eluxadoline, and lenvatinib mesylate. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is soliciting information on issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Center for Devices and Radiological Health Appeals Processes,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
A House appropriations subcommittee has approved a 2017 funding bill that would provide FDA $2.7 billion in discretionary spending, a $33 million (1%) increase over fiscal year 2016 spending levels. Including revenue from user fees, total 2017 funding is $4.78 billion – $97.4 million (2%) more than 2016.
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 3/14 Federal Register notice that requested comments on the Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The agency is taking this action in response to requests for an
FDA Policy/General
Former CDER Office of Compliance director Cynthia Schnedar has joined consulting firm Greenleaf Health as the group’s new regulatory compliance executive vice president. Schnedar resigned earlier this month, with her departure coming three months after she was recused from working on substantive issues relating to compliance actions and policy
FDA Policy/General
Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss, make
FDA Policy/General
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions
FDA Policy/General
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Bayer’s Adempas (riociguat) is 2,394 days for extending a patent which claims the human drug product. Adempas is indicated for treating adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Apoquel (oclacitinib) for extending a patent which claims the animal drug product. Apoquel is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. To
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Genentech’s Gazya is 1,698 for extending a patent which claims the human biological product. Gazyva is indicated, in addition with chlorambucil, for treating patients with previously untreated chronic lymphocytic leukemia. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is correcting a 3/7 Federal Register notice, which announced a guidance for industry entitled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products. The document was published with an incorrect docket number
FDA Policy/General
Federal Register Notice: FDA is withdrawing approval of an EMD Serono NDA for Luveris (lutropin alpha for injection). The company has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. To view this notice, click here.
FDA Policy/General
test test another test link using links from source file manager test link WSM test link WSM test link 2
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Miami Fat Supply, Inc. Groveland, FL (3/17). Inspected 10/13-14/15. QSR deviations, adulterated: The firm failed to validate a process whose results cannot be fully verified