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
Drugs
Wells Pharmacy Network has recalled all sterile human and veterinary products prepared since February due to an FDA concern over a lack of sterility assurance. “Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening,” an
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.
Biologics
FDA has approved Amgen’s Amjevita, a biosimilar copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. This is FDA’s fourth approved biosimilar. Amjevita is approved for the following indications in adult patients: * moderately to severely active rheumatoid arthritis; * active psoriatic arthritis; * active ankylosing spondylitis (an arthritis that
Drugs
Teva Pharmaceutical Industries has reported statistically significant results in a second Phase 3 registration trial involving SD-809 (deutetrabenazine) and its use for treating tardive dyskinesia. Teva expects to submit an NDA by the end of the year. In the AIM-TD trial, the primary endpoint was change in Abnormal
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.
Drugs
FDA has issued a guidance, Self-Identification of Generic Drug Facilities, Sites, and Organizations, to inform them about complying with the self-identification requirement in the Generic Drug User Fee Amendments of 2012 (GDUFA). Under that law, the document says, human generic drug facilities, sites, and organizations are required to
Drugs
Attorney Alexander Varond (Hyman, Phelps & McNamara) says that efforts are underway to reauthorize the FDA rare pediatric disease priority review voucher program that is set to expire 10/1. But it is not clear that those efforts will succeed in time, he writes in his firm’s FDA Law
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) for clinical pharmacology review of NMEs, NDAs, and BLAs. The document and its attachments establish good review practices for the three categories of reviews and is one in a series of MAPPs intended to document good review practices for review
Devices
FDA has cleared a GI View Ltd. 510(k) for its new Aer-O-Scope Colonoscope System, a disposable, self-propelled, joystick-controlled, colonoscope that features therapeutic access. “The new system has two working channels that enable therapeutic access using standard tools, such as snares and forceps, to take biopsies
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.
Drugs
FDA is interested in providing technical expertise on legislation that could curb brand name drug companies’ efforts to block or delay generic drug entry into the market, but it says any measure should be crafted with care to avoid any unintended consequences. During a Senate appropriations subcommittee hearing 9/21,
Biologics
FDA has granted Sanaria a fast track designation for its preventative vaccine for malaria, Sanaria PfSPZ Vaccine. The vaccine is in clinical trials in subjects ranging in age from 6-months to adults in the U.S., Europe and Africa. The trials are intended to finalize an immunization regimen to
Drugs
An 8/17-21/15 FDA inspection at Hebei Yuxing Bio-Engineering Co., Hebei, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 9/6 Warning Letter. Specific violations noted included: * failure to have laboratory control records that include complete data derived from
Devices
Sen. Lamar Alexander (R-TN) says that an FDA proposal to regulate laboratory-developed tests amounts to “double regulation” since the tests are already regulated by the Centers for Medicare and Medicaid Services through the Clinical Laboratories Improvement Act. At a Senate Health Committee hearing on the proposal, Alexander said
Drugs
CDER has issued a Manual of Policy and Procedures (MAPP) for its Office of Surveillance and Epidemiology (OSE) with the procedures for sharing non-public information on pending proposed drug proprietary names. The procedures are to be used by the OSE Division of Medication Error Prevention and Analysis and the