FDA Policy/General
Federal Register notice: FDA has announced a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting. The committees will discuss a Nektar Therapeutics NDA for oxycodegol, a new molecular entity full mu-opioid receptor agonist for managing chronic low
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz), indicated to reduce blood phenylalanine concentrations in certain adult patients with phenylketonuria. The regulatory review period is 3,803 days, which includes 3,474 days that occurred during the
Drugs
FDA has released a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” The document is intended to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator)
Devices
FDA has posted a draft guidance on “Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for MR coils to use for clearance under the agency’s Safety and Performance Based Pathway. Under the framework, submitters planning to submit a 510(k)
Drugs
FDA has approved an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssen’s Remicade, indicated for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The agency says this is the fourth biosimilar of Remicade (infliximab) to gain approval. To view the
Biologics
FDA appears to be stepping up its enforcement efforts against violative cell/tissue products. On 12/6, the agency warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC (Yorba Linda, CA) for processing and distributing unapproved products derived from umbilical cord blood. They were warned also on current good tissue
Drugs
A New York physician, Gordon Freedman, has been convicted for participating in a scheme to receive bribes and kickbacks through sham educational programs (“speaker programs”) from Insys Therapeutics in exchange for prescribing millions of dollars’ worth of Subsys, a fentanyl-based spray. “As a jury of his peers has now
FDA Policy/General
Federal Register notice: FDA has announced a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee joint meeting. During the morning session, the committees will discuss an Esteve Pharmaceuticals NDA for a combination tramadol 44 mg and celecoxib 56 mg
Drugs
FDA says it is asking manufacturers of ranitidine (Zantac) and nizatidine (Axid) to expand their testing for N-nitrosodimethylamine (NDMA) in all lots of the medications before making them available to consumers. An agency statement says that if testing shows NDMA above the acceptable daily limit of 96 nanograms/day
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111” (OMB Control Number 0910-0606). FDA regulations in 21 CFR Part 111 establish minimum GMP requirements pertaining to the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice” (OMB Control Number 0910-0543). FDA regulations require domestic and foreign establishments that recover, process,
Drugs
ViiV Healthcare has submitted an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection. The drug is under development for combination use with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify the agency in writing. It is also requesting nominations such representatives. To view the notice, click here.
Drugs
The CDRH Manufacturer and User Facility Device Experience (MAUDE) database does not make public information on the sex of patients involved in a medical device adverse event for reasons of “patient confidentiality.” However, the CDER FDA Adverse Events Reporting System (FAERS) makes such information publicly available. Because the International Consortium
Devices
FDA has authorized marketing of Roche Molecular Systems’ new diagnostic test based on bacterial viability and novel technology to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization. An agency statement says the cobos vivoDX MRSA diagnostic test may allow healthcare professionals to evaluate patients for colonization with MRSA bacteria more
Biologics
The CBER Office of Compliance and Biologics Quality says Chara Biologics, Woodland Hills, CA, is marketing its unapproved CharaCore product to consumers, including parents of children with autism. According to an FDA letter to the company, the firm’s Web sites say that CharaCore contains “umbilical, cord tissue, and amniotic
Drugs
FDA has approved three ANDAs for the first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult patients. Approvals were granted to HEC Pharm Co., Biocon Limited and Sun Pharmaceutical Industries. An FDA release says that fingolimod must be dispensed with a Medication Guide
Drugs
FDA has launched CURE ID, an Internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a Web site, smart phone, or other mobile device. An agency statement says the platform “enables
Drugs
Genus Lifesciences says FDA applied a different and much more lenient standard to an application submitted by Lannett for its cocaine hydrochloride product that Genus says is substantially similar to its Goprelto product. In an 11/27 letter, Genus says that FDA required it to submit results from several studies
Devices
The Obesity Action Coalition and American Society for Metabolic and Bariatric Surgery say an FDA discussion paper on benefit/risk approaches for weight loss medical devices may not recognize that treating the chronic disease of obesity requires a full continuum of care. The groups’ comment letter says that discussion paper
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.” The document provides FDA’s recommendations for clinical trials intended to establish clinical effectiveness and safety for such drugs. To view the notice, click here.
Devices
FDA has cleared an EmCyte 510(k) for its Progenikine Concentrating System for adipose lipoplasty. The company says the device is cleared for all medical procedures involving the harvesting and transferring of autologous adipose tissue. It is designed for pure extraction and centrifugal preparation of adipose concentrate at the point