FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Adamson Analytical Laboratories, Inc. Corona, CA (8/2). Inspected 8/4-14/15. CGMP deviations, adulterated: The high performance liquid chromatography (HPLC) and gas chromatography (GC) data acquisition systems
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee 9/20-21, from 8 a.m. to 6 p.m. at Hilton Washington, DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Survey of Alumni Commissioner's Fellowship Program Fellows,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The information from Alumni CFP Fellows will allow FDA’s Office
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Ulcerative Colitis: Clinical Trial Endpoints. It aims to assist sponsors in the clinical development of drugs for treating ulcerative colitis (UC) in adult and pediatric patients and addresses FDA’s current thinking on efficacy endpoints for UC
FDA Policy/General
Federal Register Notice: FDA is making available the draft guidance entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device. It is aiming to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device. FDA intends to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period on the potential development of a user-fee program for nonprescription (over-the-counter) monograph drugs. The agency sought comments in the 5/11 Federal Register that announced a 6/10 public meeting on the topic. FDA will hold a Webinar
FDA Policy/General
Federal Register Notice: FDA is completing the target of the goal established to address CDRH’s 2014-2015 Strategic Priority “Strike the Right Balance Between Premarket and Postmarket Data Collection.” To achieve this strategic priority, CDRH established a goal to facilitate and expedite the development and review of medical devices,
FDA Policy/General
Federal Register Proposed rule/direct final rule: FDA is issuing a proposed rule describing when it would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for agency review. Under the proposed rule, FDA would refuse to accept a
FDA Policy/General
Federal Register Direct final rule: FDA is confirming the effective date of 9/16 for the 5/4 final rule that amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. The agency aims to update outdated requirements,
FDA Policy/General
BIOLOGICS Guidance on Blood Donors for Autologous Use Federal Register Notice: FDA is making available a document entitled Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use — Compliance Policy; Guidance for Industry. This guidance addresses the regulatory requirements for determining donor eligibility that
FDA Policy/General
Fe3 Medical, an InCube Labs company says the state of Texas has invested $3.5 million as part of an extension to the company’s Series B round to be used for product development, clinical trials and regulatory submissions required to obtain FDA approval for the transdermal patch for patients
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
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
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
FDA Policy/General
U.S. marshals, on behalf of FDA, have seized more than 100 cases of products labeled as containing kratom from Nature Therapeutics LLC, which does business as Kratom Therapy (Grover Beach, CA). The U.S. Department of Justice has filed a complaint in central California federal court, alleging that the
FDA Policy/General
Former FDA Webview consulting editor and longtime FDA stalwart John H. Scharmann died in hospice care 8/3 at the age of 84, after a lengthy, valiant battle with kidney disease. He leaves his devoted wife Marlene, daughter Beth and son Phil, three grandchildren and two great-grandchildren. Scharmann joined