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,
Drugs
FDA has granted fast track status to Calithera Biosciences for CB-839 and its use in combination with cabozantinib for treating patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the
Drugs
Speaking 4/17 at the National Policy and Advocacy Summit on Biologics and Biosimilars, CDER Office of New Drugs associate director Leah Christl said that over time the U.S. will see a dramatic increase in the number of biosimilar approvals, based on the quantity of applications that the agency
Drugs
FDA says a draft guidance, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations, is available. A 4/19 Federal Register notice says the guidance’s purpose is to provide recommendations to industry in the development and manufacture of inhalation aerosols. The draft describes points to
Drugs
A 7/24-7/26/17 FDA inspection at McCallum Manufacturing, South Yorkshire, UK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/9 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,
Devices
FDA has approved a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility. The devices are being made under “an improved manufacturing process,” according to Sientra. “We will continue our precision-controlled selling
Devices
A coalition of 50 environmental, public health, and children’s rights groups is calling on FDA to “bring its policies FDA in line with the federal government as a whole” and to “publicly advise a phase down of the use of mercury amalgams with the goal of phasing out entirely”
Biologics
Reacting to an incident in which a south Florida clinic performed unproven stem cell treatments that left three female patients blind, Sen. Charles Grassley (R-IA) has asked HHS and FDA for additional information. Grassley’s letter to the agencies cited a Washington Post report indicating that the three women
Drugs
FDA medical reviewers say three clinical trials conducted by GW Pharma “provide substantial evidence of the effectiveness of CBD (cannabidiol) for the treatment of seizures associated with Lennox-Gestaut syndrome (LGS) and Dravet syndrome (DS) in patients two years of age and older.” The assessment is included in a briefing
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.” The document clarifies FDA’s policy on compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document describes an optional streamlined submission process to determine whether an investigational in vitro diagnostic in an oncology clinical trial under an IND (an
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Special Protocol Assessment (SPA)” that provides information about the procedures and general policies adopted by CDER/CBER for such assessments. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and the interactions between sponsors
Devices
FDA has released a new Medical Device Safety Action Plan outlining a vision for how the agency can continue to enhance its programs and processes to assure medical device safety. The plan reorganizes what has long been the agency’s most troubled Center. FDA commissioner Scott Gottlieb says the agency
Drugs
A 9/25-9/28/17 FDA inspection at Luen Wah Medicines, Hong Kong, found significant violations of current good manufacturing practice regulations (CGMP) for finished pharmaceuticals, according to a 4/6 Warning Letter. Specific violations cited in the letter were: * failing to perform, for each batch of drug product,
Devices
An 8/14-8/18/17 FDA inspection at SynCardia Systems, Tucson, AZ, found Medical Device Reporting violations associated with the firm’s manufacturing of the SynCardia Total Artificial Heart System, according to a 4/3 Warning Letter. Specific violations cited in the letter were: * failing to report to FDA
Drugs
A bipartisan group of four senators has introduced legislation they say will help bring non-opioid or non-addictive pain medications and treatments for substance abuse disorders to patients more quickly. The bill was introduced by Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Joe Donnelly (D-IN) and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hanbul Cosmetics Co. Republic of Korea (3/29): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm could not provide