FDA Policy/General
FDA acting commissioner Ned Sharpless told the Food and Drug Law Institute’s annual meeting 5/2 he plans to heed the advice he heard most frequently from former commissioners he consulted before he moved to the agency last month from NIH: “Listen to the FDA experts around you.” Sharpless
Drugs
FDA has approved an Agios Pharmaceuticals supplemental NDA to update the U.S. prescribing information for Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are 75 years
FDA Policy/General
Federal Register notice: FDA has announced a 6/5 public meeting entitled “International Cooperation on Cosmetics Regulation (ICCR) — Preparation for ICCR-13 Meeting.” The meeting is intended to receive public input on various topics pertaining to cosmetic regulation. To view the notice, click here.
Biologics
FDA has approved a Sanofi Pasteur BLA for Dengvaxia, the first vaccine approved for preventing dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages nine through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic
Drugs
Eight public health advocacy organizations are asking FDA acting commissioner Norman Sharpless to continue to reform the monograph system for over-the-counter (OTC) drugs. In a 4/24 letter, the groups (American Academy of Allergy, Asthma, and Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products
Devices
CDRH says it is reorganizing “to create an agile infrastructure that can adapt to future organizational, regulatory, and scientific needs.” An online post says implementation of the reorganization is taking a phased approach that started 3/18 and will be completed by 9/30. The post says that once fully
Drugs
The House Judiciary Committee has unanimously passed four bills to address prescription drug pricing. A committee media release says that marking up and advancing the four bills is part of the first phase of the committee’s agenda to lower the cost of prescription drugs. The bills are: * H.R.
Devices
CDRH Office of Compliance materials engineer Scott McNamee says a final guidance on the use of animal tissues in the manufacture of medical devices succeeds a 1998 guidance that gave the FDA understanding of how to address the risk to the public health from bovine spongiform encephalopathy (BSE). “Since 1998,
Drugs
FDA has issued a complete response letter to Heron Therapeutics for its NDA for HTX-011 to manage postoperative pain. The agency told the company it could not approve the NDA in its present form based on the need for additional CMC and non-clinical information. FDA did not identify
Devices
FDA has cleared a Surgical Information Sciences 510(k) to market new visualization capabilities for its deep brain stimulation (DBS) software. Prior to this expanded clearance, the software was cleared for visualization of brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a DBS
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Mammography Quality Standards Act Requirements — 21 CFR Part 900” (OMB Control Number 0910-0309). The collection is related to the federal certification and inspection program for mammography facilities, regulations and standards for accreditation and certification bodies for
FDA Policy/General
Federal Register notice: FDA has announced an 8/8 public workshop entitled “Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients” that is intended to discuss the scientific and clinical trial design considerations for development of antiviral products to treat adenoviral infection. Discussions are also planned
Drugs
FDA is struggling to figure out how best to regulate hemp-based cannabidiol (CBD) products after a provision in the 2018 Farm Bill clarified that hemp and hemp products are legal. Shortly after the bill’s passage, former FDA commissioner Scott Gottlieb issued a statement acknowledging that “Congress explicitly preserved
Drugs
FDA has sent Nabriva Therapeutics a complete response letter on its NDA for Contepo (fosfomycin) injection for treating complicated urinary tract infections, including acute pyelonephritis. The letter cited issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers that must be resolved before FDA can
Devices
Three K&L Gates attorneys say revisions to the AdvaMed Code of Ethics on medical device company interactions with healthcare professionals, scheduled to take effect 1/1/20, provide “helpful clarifications and additional detail about how best to structure arrangements between companies and healthcare professionals.” They recommend that companies
Devices
A 9/20-9/25/18 FDA inspection at Surgisil, Plano, TX, found that the firm is manufacturing the Perma Facial Implant without an approved PMA or IDE in effect. A 4/15 Warning Letter says the company has a cleared 510(k) for the device “intended for use in
Drugs
A 3/26-3/30/18 FDA inspection at Newton Laboratories, Conyers, GA, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 4/23 Warning Letter says the violations also included misbranded new drugs and unapproved new animal drugs. Specific violations identified in the letter were:
Drugs
FDA says it is aware of recent incidents that caused excess radiation exposure to patients due to user error with certain systems used to produce rubidium Rb 82 injection for use with positron emission tomography (PET) myocardial perfusion imaging scans. An agency online notice says FDA is requiring safety labeling
Devices
FDA has cleared a VivaQuant 510(k) for its RX-1 wearable device, which is intended to continuously monitor a patient’s ECG and identify arrhythmias. Collected data from the wearable is communicated to the cloud using a built-in cellular connection, the company says. “Skilled staff in a U.
Drugs
FDA has approved a Vertex Pharmaceuticals’ supplemental NDA for Kalydeco (ivacaftor) to expand its use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the drug
Drugs
FDA has approved an AbbVie supplemental NDA for Mavyret (glecaprevir and pibrentasvir) tablets to expand treatment in all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Previously, the product was approved to treat HCV in adults. Expanded approval was based on safety and efficacy data
Drugs
FDA has approved Becton Dickinson’s BD ChloraPrep skin preparation with sterile solution, a chlorhexidine gluconate antiseptic. The company says it uses a proprietary and patented process to sterilize the antiseptic solution inside the sealed ampoules located in the BD applicator. “With the new sterilization process in place, the BD