FDA Policy/General
AstraZeneca has withdrawn a marketing application filed with the European Medicines Agency (EMA) for ovarian cancer drug cediranib and its use in combination with platinum-based chemotherapy followed by maintenance monotherapy to treat adult patients with platinum-sensitive relapsed ovarian cancer. EMA reportedly had concerns about whether the drug’s
FDA Policy/General
Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.” The extension is being granted due to errors displayed on the FDA Web site pertaining to this guidance. To view
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Self-Identification of Generic Drug Facilities, Sites, and Organizations.” The document is intended to assist industry with meeting the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be
FDA Policy/General
Federal Register Notice: FDA has announced a 12/6 meeting of its Bone, Reproductive and Urologic Drugs Advisory Committee. The committee will discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Eisai’s NDA for Fycompa (perampanel) that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 3,274 days. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for an Amylin Pharmaceuticals NDA for Myalept (metreleptin for injection) that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 6,509 days. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for an Eisai NDA for Belviq that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 2,928 days. To view this notice, click here.
FDA Policy/General
New York University journalism professor Charles Seife says that by holding embargoed briefings for select reporters on major issues conditional that the reporters not seek comment from anyone else before the embargo is lifted, the agency is turning journalist watchdogs into lapdogs, and making reporters into stenographers. In a lengthy
FDA Policy/General
In an amicus brief filed with a Massachusetts federal court, the Medical Information Working Group asks that the court address concerns that FDA enforcement policy is not consistent with 1st and 5th Amendment principles that permit manufacturers to engage in truthful and non-misleading communications about product off-label uses.
FDA Policy/General
Federal Register Final Order: FDA has classified the Magnetic Surgical Instrument System into Class 2 (special controls). The special controls that will apply to the device are identified in the order and will be part of the codified language for the magnetic surgical instrument system’s classification. To view this
FDA Policy/General
Federal Register Notice: FDA has announced a 10/25-26 public advisory committee meeting of the Technical Electronic Product Radiation Safety Standards Committee. On 10/25, the committee will discuss and make recommendations on possible FDA performance standards for the following: Radiofrequency radiation products, such as microwave ovens and wireless
FDA Policy/General
Federal Register Final Order: FDA has classified the strabismus detection device into Class 2 (special controls). The special controls are identified in this order and will be part of the codified language for the strabismus detection device’s classification. To view this order, click here.
FDA Policy/General
Federal Register Notice: FDA has released a draft guidance entitled “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.” The document is intended to clarify how the agency applies certain factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that
FDA Policy/General
Reps. Fred Upton (R-MI), chairman of the House Energy and Commerce Committee, and Rep. Tim Murphy (R-PA), who heads the committee’s Oversight and Investigations Subcommittee, are asking (includes link to committee letter) FDA for an update on its Office of Criminal Investigations (OCI) in the wake of
FDA Policy/General
Federal Register Notice: FDA has announced the availability of a draft guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” The document is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who
FDA Policy/General
Federal Register Notice: FDA has released a guidance entitled “Reporting of Computational Modeling Studies in Medical Device Submissions.” The document provides recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation studies that are used as valid scientific evidence to support medical device submissions,
FDA Policy/General
Federal Register Notice: FDA has announced a publication containing modifications to the agency’s list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The document, “Modifications to the List of Recognized Standards, Recognition List Number: 045,” is intended to assist manufacturers who elect to declare
FDA Policy/General
Federal Register Notice: FDA is suspending approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous versions of chloramphenicol were withdrawn from sale for reasons of safety or effectiveness. The agency says it will not accept or approve ANDAs for chloramphenicol capsules, 50 mg and 100 mg,
FDA Policy/General
The 2nd Circuit Court of Appeals has ruled that a Lanham Act false advertising claim brought by Church & Dwight against Swiss Precision Diagnostics (SPD) over its Clearblue Advanced Pregnancy Test with Weeks Estimator is not precluded by the Federal Food, Drug, and Cosmetic Act (FFDCA). Church & Dwight claimed
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Option Care Enterprises, Inc. Everett, WA (9/7). FDA investigators inspected the drug compounding operation and observed deficiencies in its practices for producing sterile drug products. For example, the
FDA Policy/General
Federal Register Notice: FDA’s Risk Communication Advisory Committee has planned an 11/7 meeting to discuss and make recommendations on the agency’s draft “Strategic Plan for Risk Communication and Health Literacy.” The plan is intended to clarify how the agency can communicate the benefits and risks of FDA-
FDA Policy/General
Federal Register Notice: FDA is announcing the 2016 FDA Naloxone App Competition, a prize competition designed to help reduce deaths associated with prescription opioid and heroin overdose by seeking innovative approaches to help reduce preventable harm associated with the drugs. The goal is to spur innovation around the development of