FDA Policy/General
Federal Register Notice: FDA is making available guidance for industry entitled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act. It describes FDA's interim regulatory policy on outsourcing facilities that compound human drug products using bulk drug substances
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. It describes FDA's interim regulatory policy on the use of bulk drug substances by licensed pharmacists in
FDA Policy/General
Federal Register Final order: FDA is classifying the nasolacrimal compression device into Class 1 (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. The classification was applicable on 4/20. To view this notice, click here.
Drugs
FDA has granted tentative approval to Upsher-Smith Laboratories for its supplemental NDA for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults. Company chief scientific officer William Pullman says that there are no extended-release topiramate formulations approved for migraine prophylaxis in the
Drugs
Salix Pharmaceuticals has agreed to pay $54 million to the U.S. government to settle a civil fraud lawsuit that alleged the company had violated the federal Anti-Kickback Statute and False Claims Act by using its “speaker programs” as a mechanism to pay kickbacks to doctors to induce them
Devices
Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a patient’s
Devices
FDA has told Terumo Cardiovascular Systems that it has successfully completed its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, MI manufacturing facility, including Terumo Advanced Perfusion System 1, that were impacted by a 2011 consent decree. As a result, all shipping restrictions
Devices
FDA has issued a draft guidance, Dissemination of Patient-Specific Information from Devices by Device Manufacturers, to “facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients.” The document notes that patients increasingly are seeking to
FDA Policy/General
A new report from the National Academies of Sciences, Engineering, and Medicine says that while the emerging science of gene drives has the potential to address environmental and public health challenges, gene-drive modified organisms are not ready to be released into the environment and require more laboratory research and
Drugs
Members of FDA’s Anesthetics and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Committee voted 9-6 on 6/8 to support the safety and efficacy of Pfizer’s NDA for Troxyca ER (oxycodone HCl and naltrexone HCl extended-release capsules). The company is seeking
Drugs
FDA has issued two interim guidance on the use of bulk drug substances in compounding under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. An agency statement (includes links to guidances and other documents) says the guidances explain FDA’s policy about the conditions under which
Drugs
As part of its involvement in Interpol’s 5/31-6/7 Ninth Annual Internet Week of Action (Operation Pangea IX), FDA took action against 4,402 Web sites, asking their domain registrars to suspend them for illegally selling potentially dangerous unapproved prescription drugs to U.S. consumers. The agency
FDA Policy/General
Federal Register Final rule: FDA is terminating the Transmissible Spongiform Encephalopathies Advisory Committee effective 6/9. In recent years, the number of issues requiring committee advice has declined, and it has met very infrequently and thus the effort and expense of maintaining this advisory committee is no longer justified. Any
Drugs
FDA has approved a new formulation of ThromboGenics’ Jetrea (ocriplasmin) — an already-diluted formulation that eliminates the current preparatory dilution steps prior to injection. Jetrea is approved in the U.S. for treating symptomatic vitreomacular adhesion (VMA), an age-related progressive, sight-threatening condition that may lead to visual distortion,
Devices
FDA has cleared an Astute Medical 510(k) for the NephroCheck Test Kit that will extend its shelf life from 16 weeks to 12 months when refrigerated. The test is designed to help determine if certain hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI)
Drugs
KemPharm has filed an NDA amendment for Apadaz (benzhydrocodone hydrochloride and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The amendment is focused on providing the agency additional information KemPharm seeks to include in the FDA's current NDA review, the company
Drugs
FDA has accepted for review an Ironwood Pharmaceuticals and Allergan supplemental NDA for a 72 mcg dose of linaclotide for use in treating adults with chronic idiopathic constipation (CIC). The submission is based on efficacy and safety data from a double-blind, placebo-controlled Phase 3 clinical trial involving 1,
Devices
FDA has cleared a Sandstone Diagnostics 510(k) for its Trak Male Fertility Testing System, an at-home diagnostic for couples to measure semen quality at home as they try to conceive. The device uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges, according to
Drugs
Sen. Dan Coats (R-IN) has introduced S. 2998, the Ensuring Patient Access to Critical Breakthrough Products Act, to “establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.” In a statement, the senator says that “researchers and entrepreneurs
Devices
Baxter says that unauthorized third-party services who refurbish, recondition, rebuild, remarket, remanufacture, and service medical devices “generally lack the product and process knowledge and controls of the original equipment manufacturer. Unauthorized service activities, therefore, may create significant risks for patients, despite the best intentions and efforts of the third-
FDA Policy/General
Federal Register Notification of withdrawal: FDA is withdrawing approval of five NADAs and an ANADA. This action is being taken at the sponsors’ request because these products are no longer manufactured or marketed. These are Cross Vetpharm’s Sulfa-Nox Liquid, Sulfa-Nox Concentrate, Erythromycin Medicated Premix, Purina Sulfa, Supersweet
Drugs
A joint meeting by FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 14 to 3 to support approval of Teva’s Vantrela ER (hydrocodone bitartrate extended-release tablets) for managing pain severe enough to require long-term opioid treatment