Drugs
A just-completed FDA inspection of Lupin Ltd.’s Madhya Pradesh, India manufacturing facility has resulted in a six-observation Form 483 related to GMP deviations at the plant. For example, agency investigators said the firm invalidated 96% of all the out-of-specification results obtained during testing of commercial
Drugs
OncBioMune Pharmaceuticals has submitted to FDA a Phase 2 clinical trial protocol for ProscaVax, a novel therapeutic cancer vaccine for early stage prostate cancer. In the trial, ProscaVax will be evaluated for safety, tolerability and efficacy as a treatment for patients with a new disease diagnosis and who have chosen
Drugs
FDA has cleared a GenePOC 510(k) for its GBS LB assay and its revogene instrument, a molecular diagnostic for identifying antepartum Group B Streptococcus colonization in newborns. Clearance was based on data from a clinical validation study that compared the assay to a standard culture. The assay used vaginal
Drugs
OncBioMune says it has submitted to FDA its protocol for an upcoming Phase 2 trial of ProscaVax as a novel therapeutic cancer vaccine for early-stage prostate cancer. The company says the trial will evaluate the agent for safety, tolerability, and effectiveness as a treatment for patients at disease presentation
Drugs
The HHS Office of Inspector General (OIG) says settlements were reached with a drug company and a durable medical equipment company during the six months ending 3/31. In a semi-annual report to Congress covering the period 10/1/16 to 3/31, the OIG says Shire entered into
Devices
On board for less than a year, CDRH Office of Device Evaluation director John Sheets has left the agency to “pursue other opportunities,” an FDA spokeswoman tells FDA Webview. Center chief scientist Willaim Maisel has assumed acting ODE director duties until a replacement is found. Sheets replaced former director Christy
Drugs
FDA has published the FDA-483 issued following a 4/17-5/10 agency inspection at Qualgen, Edmond, OK, an outsourcing facility. The five inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its
Drugs
National Institutes of Health (NIH) director Francis Collins says in an online agency blog post that the scope of the nation’s opioid crisis is staggering but not hopeless, and NIH has a plan to accelerate research in three critical areas. He says there is a need for: * additional overdose-
Drugs
FDA has released the FDA-483 issued following its 3/3-3/23 inspection at Fusion IV Pharmaceuticals, Los Angeles, CA, a producer of sterile drug products. Observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * · failing to have procedures designed
Biologics
Figures released by FDA show that the agency performed about 2,500 human cells, tissues, and cellular and tissue-based products inspections in fiscal years 2012-2016. The online chart lists the total number of inspections per year with the average number of hours per inspection, and the number of
Drugs
FDA has approved a Nexus Pharmaceuticals ANDA for generic sodium nitroprusside injection, indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute
Devices
FDA has approved a Roche PMA for its Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Novartis’ Zykadia (ceritinib). The agency 5/30 approved the expanded use of Novartis’ Zykadia (ceritinib)
FDA Policy/General
As FDA extends its medical product safety-effectiveness intelligence gathering into private sector “real world evidence,’ a False Claims Act settlement by one of the nation’s largest vendors of electronic health records (EHR) software, eClinicalWorks, could cast a shadow on the reliability of such data. FDA sees its ongoing
Drugs
FDA has approved multiple drug manufacturers’ ANDAs for the first generic versions of Eli Lilly’s Strattera (atomoxetine) for treating attention-deficit/hyperactivity disorder in pediatric and adult patients. Approvals were granted to Apotex, Teva Pharmaceuticals USA, Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited for multiple strengths of the drug
Drugs
A Lachman Consultants blog post says that both FDA and industry realize that the only real way to cut down on FDA’s ANDA review workload is to get it right the first time. “Industry continues to say with the constantly changing requirements and FDA expectations, it makes this very
Drugs
Ohio attorney general Mike DeWine has filed a state law suit against five leading prescription opioid manufacturers and their related companies in a county common pleas court in an area of the state that he says was likely the hardest hit place in the country for the opioid epidemic. The
FDA Policy/General
Former FDA regulatory counsel Deborah Livornese has joined Arnall Golden Gregory as counsel in its food and drug practice, focusing on a broad range of FDA matters concerning prescription and OTC drugs, medical devices, biological products, and cosmetics. She intends to advise pharmaceutical drug and device companies on regulatory requirements
Drugs
An AssurX blog post says that FDA “continues to expect major improvements in pharmaceutical manufacturing quality management. While it’s anyone’s guess, given today’s federal government budget debate, it still appears likely FDA will continue its focus on GMP and data integrity issues through 2017. If an FDA
Drugs
FDA has released the FDA-483 inspection report from a 2/27-3/17 agency inspection at SterRx, a Plattsburgh, NY, outsourcing facility. The inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * procedures designed to prevent microbiological contamination of drug products purporting to
Drugs
FDA has approved Novo Nordisk’s BLA for Rebinyn (nonacog beta pegol; N9-GP) for treating adults and children with hemophilia B. The company says Rebinyn is indicated for on-demand treatment and control of bleeding episodes and the perioperative management of bleeding around the time of surgery in adults
FDA Policy/General
Federal Register notice: FDA has announced a 6/21-22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. On 6/21, information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. Products
Drugs
FDA has accepted a Pfizer supplemental NDA for Sutent (sunitinib) seeking to expand its use to include adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancer-containing kidney). The user fee review target date is 1/2018. The