FDA Policy/General
Guide on GMPs for Active Pharmaceutical Ingredients Federal Register notice: FDA makes available a final guidance entitled “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.” 04/20/2018 Draft Guide on Inhalation Drug Products Federal Register notice: FDA makes available a draft guidance entitled “Metered Dose
Drugs
The Senate Homeland Security and Governmental Affairs Committee is asking FDA for information on its 1/30 policy to ask manufacturers to limit packaging for Imodium (loperamide). The agency said it would ask manufacturers to use blister packs or other single-dose packaging to limit the number of Imodium doses
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.” The International Council for Harmonization addresses questions about implementing FDA’s guidance “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.” To view the notice, click here.
Drugs
As part of its ongoing efforts to address the opioid epidemic, FDA 4/20 released a draft guidance to help sponsors develop medication-assisted treatments (MAT) and new formulations of existing drugs that could benefit patients suffering from addiction. The document, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,” outlines
Devices
FDA has cleared a Varian 510(k) for its Calypso Anchored Beacon transponder. Used with Varian’s TrueBeam, Edge and Clinac C-series medical linear accelerators, the transponder detects slight movements of a tumor and helps clinicians deliver lung stereotactic body radiotherapy. The device is implanted in small airways within
Drugs
FDA has allowed the de novo marketing for Bruker Daltonik’s Bruker Maldi Biotyper CA system for identifying C. auris. FDA says this is the first test to identify the emerging pathogen, which can cause serious infections in hospitalized patients. The expanded detection for the test system adds the its
Drugs
A federal judge in Arkansas has entered a consent decree of permanent injunction between FDA and drug compounder Cantrell Drug Co. and its CEO James L. McCarley, Jr. The action prohibits Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with FDA regulations and requirements.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/2020. To view the notice, click here.
Drugs
The Federal Trade Commission (FTC) is appealing to the 3rd Circuit Court of Appeals a Delaware federal court decision granting a Shire motion to dismiss an FTC suit alleging that the company abused the FDA citizen petition process to prevent generic competition to its Vancocin. Attorney Jennifer Thomas (Hyman, Phelps
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products — Quality Considerations.” The document provides recommendations to industry on the developing and manufacturing such products. It applies to MDI and DPI products intended for local or systemic effect.
Devices
FDA has cleared a SpeeDx 510(k) for its ResistancePlus MG Positive Control kit, a diagnostic test that simultaneously detects M. genitalium and genetic markers for antimicrobial resistance. The kit contains synthetic DNA to simulate Mycoplasma genitalium, as well as five mutations known to confer resistance to macrolide antibiotics. Macrolide-
Devices
An Alabama federal court has ruled that a plaintiff’s claims against Allergan over its Lap-Band weight loss PMA device are preempted under federal law. Attorney Michelle Yeary (Dechert) writes in an online blog post that the claims the court ruled on involved negligence, failure to warn, and negligent
Drugs
Members of the FDA Central Nervous System Drugs Advisory Committee have voted unanimously to recommend approval of GW Pharma’s Epidiolex, which contains cannabidiol, for treating seizures associated with two rare types of childhood epilepsy — Lennox-Gestaut syndrome and Dravet syndrome. The company says that if FDA approves the drug,
Drugs
FDA medical reviewers say they have concerns about the safety of Lilly’s Olumiant (baricitinib) being proposed to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to methotrexate. The company’s NDA will be considered at a 4/23 meeting
Devices
FDA has cleared an Arthrosurface 510(k) to market the stemless OVOMotion Shoulder Arthroplasty System that the company says is intended to provide surgeons with an approach that results in increased exposure to the glenoid, minimizes bone removal, and is designed for patients with painful or severely disabled shoulder joints
Drugs
FDA has expanded approval for AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. Approval was
Drugs
FDA has published an International Council for Harmonization guidance, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients—Questions and Answers, to clarify uncertainties due to interpretation of certain sections of the ICH Q7 guidance on good manufacturing practice for active pharmaceutical ingredients (API). The document says the Q7 guidance
Devices
FDA is warning healthcare providers and facilities about the risk of cross-contamination with certain 24-hour multi-patient use endoscope connectors. “To date, FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use,” an agency notice says. The notice says
Drugs
FDA has approved a Rigel Pharmaceuticals NDA for Tavalisse (fostamatinib disodium hexahydrate) for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The oral spleen tyrosine kinase inhibitor is designed to target the underlying autoimmune cause of the disease
Devices
FDA has cleared a Cantel Medical 510(k) for its Advantage Plus Pass-Thru automated endoscope reprocessor. The device has been clinically proven to disinfect the most commonly used endoscopes, including duodenoscopes, according to the company. It uses a “unique pass-through design that supports one-way workflow to ensure
Drugs
FDA has released the FDA-483 issued following a 3/12-4/6 inspection at Coastal Meds, a Nashville, TN, outsourcing facility. Specific observations listed on the form were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * protective apparel is not worn as necessary to protect
FDA Policy/General
FDA commissioner Scott Gottlieb told Congress 4/18 that a proposed fiscal year 2019 budget increase of $663 million (13%) over last fiscal year will allow the agency to sustain its current work while adding resources for fostering innovation and competition to bring better and more affordable products to market,