Drugs
FDA has accepted for review an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients with chronic severe plaque psoriasis. The submission is supported by data from a Phase 3 one-year study and a five-year open-label extension study. The agency has set
Drugs
FDA has posted a draft guidance (XXINSERT LINKXXX) entitled “Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) ” that describes the agency’s approach for transferring protein products that were approved as NDAs to licensed BLAs that adhere to the regulatory
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: CDRH will sponsor the 2016 Experiential Learning Program (ELP). The training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The Center is inviting medical device industry,
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Actelion Pharmaceuticals’ Opsumit (macitentan) is 1,935 days for extending a patent which claims the human drug product. Opsumit is indicated for treating pulmonary arterial hypertension to delay disease progression. To view this notice, click here.
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to classify posterior cervical screw systems into Class 2 (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a prescription device used to provide immobilization
FDA Policy/General
Federal Register Notice: FDA seeks public comments on the information collection associated with the guidance for industry and FDA staff entitled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider letters,
FDA Policy/General
Federal Register Notice: FDA proposed collection of information “Investigational Device Exemptions Reports and Records,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Public Health Stakeholders,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice,
Drugs
It’s still too soon to tell whether the Justice Department’s focus on individual accountability for corporate wrongdoing will have a real and lasting impact, according to a Washington Legal Foundation Legal Backgrounder by two Bryan Cave attorneys. Although the policy announced last fall by deputy attorney general Sally
Devices
A California federal court decision involving complications allegedly caused by placement of Bayer’s controversial Essure permanent contraception device is interesting for its treatment of preemption and, even more so, for its treatment of causation, according to attorney Steven Boranian (Reed Smith), writing in an online blog post. The device
FDA Policy/General
In a Forbes blog interview, cardiologist Kevin Campbell says there are six ways that drug companies can use social media effectively while still complying with rules and regulations. He identifies them as: consumer education with disease-specific information that presents topics broadly and is relatively non-biased so that patients
Devices
FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Baha 5 SuperPower Sound Processor for use in children and adults with high degrees of mixed hearing loss. The device is designed to make difficult listening situations easier, according to the company, which describes it as the “first and
Drugs
FDA has issued Allergan a complete response letter for its prior approval supplement for Restasis (cyclosporine ophthalmic emulsion) 0.05%, multi-dose preservative-free (MDPF) formulation. In the letter, the agency requested additional CMC information for the MDPF bottle, which the company describes as a “first of its kind container
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for a generic copy of Pfizer’s Viagra (sildenafil citrate) tablets, 25 mg, 50 mg, 100 mg, indicated for treating erectile dysfunction. Teva and Pfizer settled patent litigation in 2013, with Teva agreeing not to market its product until 12/2017. Once it
Devices
FDA says a MD Biosciences laboratory-developed test for detecting Zika virus requires 510(k) clearance or PMA approval. In a just-posted letter to the company, the agency says the Zika Virus RNA by RTPCR Assay, which is intended “to provide a reliable, accurate and rapid method of testing
Drugs
FDA has issued a warning for health care professionals and patients not to use drug products produced and distributed by I.V. Specialty Ltd. (Austin, TX) due to lack of sterility assurance. On 3/7, the agency recommended that I.V. Specialty cease sterile production until appropriate corrective actions are
Drugs
While the proposed settlement between Amarin Pharma and FDA over off-label promotion of the company’s Vascepa will end that litigation when approved by the court, there remain questions about whether and how FDA and the Justice Department will pursue misbranding cases involving off-label promotion, according to an
Drugs
The average cost to develop and gain marketing approval for a new drug is now $2.558 billion, according to an analysis by the Tufts Center for the Study of Drug Development published (purchase or subscription required) in the Journal of Health Economics. The researchers say that the cost per
Drugs
The Biotechnology Innovation Organization (BIO) is asking the Appeals Court for the Federal Circuit to reconsider and clarify its decision in The Medicines Company v. Hospira. In an amicus brief filed in support of The Medicines Company’s request for rehearing by the full court, BIO says that the court’
Drugs
Attorney General Loretta Lynch says that consumers should exercise caution when considering taking a dietary supplement and talk to a doctor before making that decision. In a video produced for National Consumer Protection Week, Lynch notes that dietary supplements are not subject to FDA testing before they are shipped to
Devices
FDA has cleared a Visunex Medical Systems 510(k) for its Visunex Medical Systems PanoCam Pro Wide-field Imaging System for imaging newborn infants for vision disorders. The wireless device can help detect external, anterior, and posterior segment vision disorders that may have long-term effects, according to the company.