FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Advantage Biosciences, Inc. Newport Beach, CA (12/17/15). FDA reviewed the firm’s product labeling and its Web site at ww.resvantage.com Unapproved new animal drugs, adulterated.
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 2/25 entitled “Next Generation Sequencing-Based Oncology Panels.” Its purpose is to obtain feedback on analytical and clinical validation approaches for such panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for
FDA Policy/General
FDA should adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy, according to former deputy commissioner Scott Gottlieb. His remarks were made this week at the International Society for Stem Cell Research in Berkeley,
FDA Policy/General
FDA commissioner-nominee Robert Califf won an unanimous voice vote from the Senate Health, Education, Labor, and Pensions (HELP) Committee 1/12 to approve his nomination to become the next commissioner. The nomination now moves to the Senate floor for a full vote. Before the vote, HELP Committee chair Lamar
FDA Policy/General
Former CBER Office of Compliance and Biologics Quality deputy director Mark I. Schwartz has joined Hyman Phelps & McNamara after a 13-year career at the agency in escalating responsibility positions. At FDA, he oversaw two of the Office’s four divisions — Case Management and Inspections and Surveillance. His day-
FDA Policy/General
BIOLOGICS Panel to Discuss 2016-2017 Influenza Vaccine Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 3/4, from 8:30 a.m. to 3 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm.
FDA Policy/General
DEVICES FDA has approved the use of Animas Corp.’s Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for managing diabetes in children and adolescents, ages two to 17. The company says the system allows patients and their caregivers to view glucose data and administer insulin right from the
FDA Policy/General
Federal Register Notice: FDA is making available a draft document entitled Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry. It provides establishments that make donor eligibility determinations
FDA Policy/General
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet 2/25, from 8 a.m. to 6 p.m. and 2/26, from 8 a.m. to 1 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, and
FDA Policy/General
Federal Register Notice: FDA is extending the comment period until 2/22 in the notice entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability” that appeared in the 11/23/15 Federal Register. To view this notice, click here.
FDA Policy/General
PTC Therapeutics has completed its rolling submission to FDA of an NDA for Translarna (ataluren), an oral, first-in-class, protein restoration therapy for treating nonsense mutation Duchenne muscular dystrophy (DMD). According to the company, the therapy is designed to enable the formation of a functioning protein in patients with
FDA Policy/General
Federal Register Notice FDA will hold a public workshop 4/21 entitled “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids.” Participants will discuss the appropriate level of good manufacturing practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. The workshop will be
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period for the draft guidance entitled: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, which was first announced in the 11/7/13 Federal Register.The agency hopes to receive updated comments and any new information. To view this
FDA Policy/General
Federal Register Notice: FDA Office of Minority Health, Office of Women’s Health, CBER, CDER, and CDRH will hold a public meeting 2/29 seeking feedback and recommendations from patient groups, consumer groups, regulated industry, academia, and other interested parties on FDA’s progress in implementing the “Action Plan to
FDA Policy/General
Federal Register Final order: FDA is classifying the intravaginal culture system into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system’s classification. To view this final order,
FDA Policy/General
Federal Register Notice: FDA is amending the 11/23 Federal Register notice of a meeting of the Orthopedic and Rehabilitation Devices Panel to change the agenda on page 72972 to read in the first column as follows: The committee will discuss, make recommendations, and vote on information regarding the premarket
FDA Policy/General
Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 3/4, from 8:30 a.m. to 3 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will meet
Drugs
FDA warning and untitled letters to drug makers on their advertising and promotion violations dropped to an all-time low last year. CDER’s Office of Prescription Drug Promotion’s (OPDP) issued nine such letters in 2015, one less than it issued in 2014. In contrast, OPDP had issued on
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cadila Healthcare Ltd. Ahmedabad, India (12/23/15). Inspected two pharmaceutical manufacturing facilities in 2014: Sarkhej-Bavla Road, N.H. No. 8A, Moraiya, Tal. Sanand, Ahmedabad, Ahmedabad City 8/
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the reporting requirements contained in the draft guidance for industry and review staff entitled Target Product Profile — A Strategic Development Process Tool. Comments should be submitted by 3/7. The draft guidance is intended to provide sponsors and FDA review staff
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to require the filing of a PMA or notice of completion of a product development protocol for surgical mesh for transvaginal pelvic organ prolapse repair. To view this final order, click here.
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse repair from Class 2 to Class 3, based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this