Drugs
FDA says that the two requests in a 10/31/14 Omthera Pharmaceuticals petition and 11/2/15 supplement have already been granted by previous agency action. The petition asked that FDA (1) grant Omthera’s request for five-year new chemical entity (NCE) exclusivity for its Epanova (omega-3-
Drugs
Four Hogan Lovells attorneys say that new policies introduced by the National Institutes of Health (NIH) in recent months “put pressure on the research compliance infrastructure across a broad swath of NIH awardees, including universities, hospitals, and medical institutions.” The attorneys summarize three policies — ClinicalTrials.gov requirements, good clinical practice
Drugs
FDA has cleared a Xtant Medical Holdings 510(k) for the Irix-C cervical cage for use with autograft or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1. Previously the device was cleared only for use with autogenous bone graft. The device
FDA Policy/General
Regulatory consulting firm Greenleaf Health has brought on two former senior FDA officials — former Office of Regional Operations director David Elder and former CDRH associate director for regulations and policy Kate Cook. At Greenleaf, Elder joins the firm’s Product Quality, Manufacturing & Compliance group, where he will provide “strategic
Drugs
A 2016 update of a 2007 Tufts Center for the Study of Drug Development assessment of drug developers’ experiences with FDA’s two pediatric studies initiatives shows that pediatric regulatory science and clinical trial networks hold promise for pediatric studies. Experts were surveyed (purchase required) on progress being made under
Drugs
A 6/13-17 FDA inspection at Sekisui Medical Co., Tokyo, Japan, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/8 Warning Letter. Specific deviations included: * failing to maintain complete data derived from all laboratory tests conducted to ensure compliance with
FDA Policy/General
[Analysis by Angi Robinson and Juliet Moritz*] Anyone who works in drug development will tell you this is a business of longshots. More than 90% of the compounds that reach clinical testing fail, and many more never make it that far. Add to those long odds the enormous time and
Drugs
The Stericycle Expert Solutions Q3 recall index finds that medical device recalls were up, while drug recalls were down in the third quarter of 2016. Medical device recalls reached their highest level since at least 2000, the report says, rising by 29% over the previous quarter to 339. Recalled units
Drugs
Unger Consulting says that the number of drug GMP Warning Letters issued by FDA more than doubled to 102 in FY 2016 from 42 in FY 2015. The analysis says that the compounding pharmacy/outsourcing facility segment continues to receive disproportionate enforcement attention from the agency, receiving more than 50%
Drugs
A poll of doctors conducted by the Biologics Prescribers Collaborative, a project of the Alliance for Patient Access, on FDA’s proposed biosimilar naming guidelines, found that 80% of the respondents across multiple medical specialties preferred a meaningful four-letter suffix that noted the biosimilar manufacturer’s name, rather than
Drugs
Attorney James Beck (Reed, Smith) looks at five ways in which a Trump administration might affect the drug and medical device product liability space: * FDA’s proposed final rule to abolish generic preemption by enacting regulations that likely violates the Federal Food, Drug, and Cosmetic Act’s “sameness” requirement for
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) is asking interested drug companies to submit proposals to serve as a location for the OPQ staff experiential learning site visit program. A Federal Register notice says that a critical part of the Center’s commitment to make safe and effective high-quality
Drugs
Federal Register Notice: FDA has issued a debarment order against Louis Daniel Smith from providing services in any capacity to a person that has an approved or pending drug product application. The order us based on Smith having been convicted of felonies under federal law for conduct relating to the
Drugs
FDA has granted Novartis a priority review for an NDA for midostaurin, indicated for treating acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for treating advanced systemic mastocytosis (SM). A PMA for the midostaurin FLT3 companion diagnostic, developed
Drugs
An FDA-ordered safety study of Pfizer’s arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiovascular risk in patients treated with prescription doses of celecoxib, ibuprofen and naproxen who had a clinical diagnosis of osteoarthritis or rheumatoid arthritis, were at high risk for cardiovascular disease, and required daily treatment
Drugs
FDA says it has amended its electronic submission “Technical Rejection Criteria for Study Data” to require study data standards in conformance to required standards specified in the FDA Data Standards Catalog for clinical and nonclinical studies that start after 12/17. Technical rejection criteria are being added to the existing
Drugs
DEVICES CapsoVision has obtained 510(k) clearance for the CapsoCam Plus small bowel capsule endoscope system. The device comprises a capsule endoscope, a retrieval kit, a data access system, and software, which work together to provide a “streamlined, patient-friendly examination,” the company says. FDA clears an EOS Imaging 510(
Drugs
FDA has approved a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease. “Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than
Drugs
FDA has granted Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for treating patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of
Drugs
Retrophin has reached an agreement with FDA under a Special Protocol Assessment (SPA) for a Phase 3 clinical trial evaluating RE-024, an investigational replacement therapy for treating pantothenate kinase-associated neurodegeneration (PKAN). The SPA provides agency concurrence that the trial’s design can adequately support a future NDA submission.
Drugs
President-elect Donald Trump has reportedly selected former HHS official Andrew Bremberg to lead the transition team for HHS. Bremberg, who worked at the agency under President George W. Bush, was more recently a policy advisor to Senate majority leader Mitch McConnell and an advisor on Wisconsin governor Scott Walker’
Drugs
The HHS Office of Inspector General 2017 work plan includes five items relating to FDA oversight of drugs and medical devices. The document lists: * evaluation of hospitals’ reliance on drug compounding outsourcing facilities; * FDA’s review of networked medical device cybersecurity during the premarket process; * response planning for a networked