Drugs
FDA says the National Academies of Science, Engineering & Medicine (NASEM) will conduct research to help inform the public and agency policies regarding compounded drugs. An agency statement also says FDA has expanded its agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation
FDA Policy/General
Federal Register notice: FDA has reopened the comment period related to two draft guidance documents entitled “Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies” and ”Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies Draft Companion Guidance Document.” Comments can be submitted until 12/26. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of seven ANDAs from multiple applicants after they notified the agency in writing that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Insanitary Conditions at Compounding Facilities.” The document is intended to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions. It is also intended to help state regulatory agencies understand some examples of what FDA
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.” The document describes how FDA intends to apply section 503B of the federal Food, Drug, and Cosmetic Act to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions where the
FDA Policy/General
Federal Register notice: FDA has announced the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2019 — $2,457,140. The voucher fee is expected to be paid in addition to any drug user fee required for such an application. To view the notice,
Devices
FDA is asking manufacturers of pen needles used with pen injectors to deliver medication to consider changing the labeling by adding a Warning that both the outer cover and the inner needle cover should be removed before an injection. The letter says FDA is aware that in some cases, the
Drugs
FDA has released the FDA-483 with two observations from a 9/10-9/14 inspection at Sun Pharmaceuticals Industries, Punjab, India. The inspection observations were: * the quality control unit lacks the responsibility and authority to approve and reject all in-process materials and drug products; * the written stability testing
Drugs
FDA has released the FDA-483 issued following an 8/20-8/24 inspection at Strides Pharma Science, Karnataka, India. The three inspection observations on the form were: * · written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment, and materials used and parameters relevant
Drugs
FDA has granted HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with primary sclerosing cholangitis (PSC), which HighTide describes as a chronic, progressive liver disease characterized by inflammation and fibrosis of the bile ducts, leading to the formation of multifocal bile duct strictures.
Devices
CDRH chief medical officer William Maisel has reaffirmed the agency’s intention to modernize its Quality System regulation (QSR) for medical devices by harmonizing and “supplanting” existing requirements with the specifications in ISO 13485:2016. The agency noted its desire to harmonize the QSR in a Unified Agenda notice earlier
Drugs
FDA has approved an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, a swallowable gas-filled intragastric balloon system for treating obesity. The inflation device is intended to be marketed with the Obalon Navigation System, which is designed to eliminate the
Drugs
Endo says it has agreed to an additional stay of its suit against FDA seeking a declaration that the agency’s interim policy on drug compounding using bulk drug substances is contrary to law because it authorizes bulk compounding of new drugs where the applicable Drug Quality and Security Act
Drugs
FDA has released the FDA-483 issued following an 8/13-8/28 inspection at Pharm D Solutions, a Houston, TX, outsourcing facility. The 16 observations on the form were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * the
Drugs
Neurelis has filed an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures. The proprietary formulation of diazepam incorporates a combination of a vitamin E-based solution
Devices
FDA has cleared a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System. The device is made using the company’s proprietary 3D-printed titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone, the company
FDA Policy/General
Federal Register notice: FDA has announced an 11/2 joint Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss the efficacy, safety, and benefit-risk profile of a Sage Therapeutics NDA for brexanolone 5 mg/mL intravenous injection, indicated for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.” The draft clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. To
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “ANDA Submissions — Content and Format.” The document details the information that should be provided in each section of the common technical document format and identifies supporting guidance documents and recommendations to assist applicants in preparing their ANDA submission. To
Drugs
The American Medical Association (AMA) says it “strongly supports accelerating and expanding regulatory action to increase pharmaceutical market competition and combat anti-competitive practices.” Responding to an FDA public hearing on competition and innovation in the biological products marketplace, the association says it strongly supports FDA efforts to ensure a
Drugs
AstraZeneca says an FDA draft guidance on use of liquids and/or soft foods as vehicles for drug administration “provides a useful framework for the selection and assessment of vehicles for alternative dosing” and is based on good scientific practice. The company cautions that although the guidance is applicable to
Drugs
While the pediatric exclusivity extension has generated new pediatric indications for several drugs, it also has led to substantial rewards to drug manufacturers. That’s the conclusion of a study of pediatric clinical trials reported in JAMA Internal Medicine. The study authors from Harvard Medical School and several academic medical