Devices
FDA has cleared a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment. The device collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a Web-based portal for review by a physician through a mobile application. “This is
FDA Policy/General
Federal Register Notice: FDA has released a draft guidance on “Physiologically Based Pharmacokinetic Analyses — Format and Content.” The document recommends the format and content for submitting physiologically-based pharmacokinetic analyses to FDA to enable efficient and consistent reviews. To view the guidance, click here. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Bristol Myers Squibb’s lung cancer therapy Opdivo (nivolumab) for patent extension purposes is 3,071 days. Of this time, 2,925 days occurred during the testing phase, while 146 days occurred during the approval phase. To view the
Drugs
FDA has released a draft guidance on “Physiologically Based Pharmacokinetic Analyses — Format and Content” that outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to support applications. To enable efficient and consistent review, the document recommends including the following five sections in a
Drugs
FDA has granted Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients who are at high risk for the condition. “Despite current antibiotic treatments, S. aureus pneumonia has a mortality rate as high as 30% in this patient population, according to the company. ASN100
Biologics
FDA commissioner Robert Califf and two agency colleagues say that while the agency is committed to facilitating development and ultimate licensure of safe, effective stem-cell therapies, the lack of scientific evidence in some claims is “worrisome.” Writing in the New England Journal of Medicine, Califf et al say that
Devices
FDA says that Medtronic has recalled four of its neurovascular products due to potential separation and detachment of polytetrafluoroethylene (PTFE) coating. The FDA notice says this is a Class 1 recall. The affected products are pipeline embolization device, alligator retrieval device, marathon flow directed micro catheter, and X-celerator hydrophilic
Drugs
FDA could see a $500 million funding boost over the next 10 years after the House passed the 21st Century Cures Act in a 392-26 vote Wednesday (11/30) night. The bill now heads to the Senate and could be voted on as early as next week. The White
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy. The user fee review target action date is 3/
Devices
FDA has cleared a BrightWater Medical 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which prevent urine in the kidneys from draining to the bladder. The device is implanted once and converts from a catheter to a stent in an office procedure without the need for
Drugs
FDA says changes have been made to the list of approved REMS (Risk Evaluation and Mitigation Strategies). The updates include: * Ariad’s Iclusig REMS modified to update data on incidence of arterial occlusive and venous thromboembolic events; * Endo’s Xiaflex REMS modified to remove the communications plan and make other
Drugs
Two lengthy, detailed reports from the Project on Government Oversight (POGO) “document the extent to which FDA depends upon funding from the pharmaceutical industry — money that comes with extraordinary strings attached.” The group calls on Congress to reject the latest reauthorization of the Prescription Drug User Fee Act (PDUFA) and
Drugs
Egalet Corp. has filed a supplemental NDA for Oxaydo (oxycodone HCl) tablets for an abuse-deterrent label claim for the intravenous route of abuse. The sNDA includes Category 1 in vitro data that demonstrate Oxaydo resists extraction of oxycodone and, based on its gelling properties, is more difficult to draw
Drugs
CDER has issued its latest quarterly report on the work of its Data Standards Program Board, which is the governing body for data standards initiatives. A data standards program action plan calls for quarterly updates to internal and external stakeholders with an overview and progress update of current data standards
Drugs
FDA has denied petitions filed by Sun Pharmaceutical and Emcure Pharmaceuticals asking it to determine that Wyeth’s original Protonix IV for injection was not withdrawn for reasons of safety or efficacy and thus an ANDA could be filed citing the Wyeth formulation. The denial letter says that based on
Drugs
Pfizer says its pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of biosimilar candidate PF-05280014 versus Genentech’s Herceptin (trastuzumab), met its primary endpoint. “The trial demonstrated equivalence in the primary endpoint of objective response rate (ORR) of PF-05280014 versus Herceptin, taken in combination with paclitaxel,
Drugs
FDA has set a user fee review goal date of 7/7/2017 for an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell disease. The submission is based on data from a Phase 3 study that demonstrated a reduction in the frequency
Drugs
FDA published 11/29 in the Federal Register a final rule specifying import data that must be submitted through the agency’s Automated Commercial Environment (ACE) when an FDA-regulated product is offered for import into the U.S. Writing in an FDA Voice blog post, agency deputy commissioner for
Drugs
Prescription Lab Compounding Pharmacy and Stonegate Pharmacy have been cited in two recent Warning Letters as part of FDA’s increased scrutiny of drug compounding operations. In a Warning Letter to Prescription Lab, the agency said it observed a serious deficiency in its practices for producing sterile drug products. Specifically,
Drugs
The day before the House approved (see related coverage) it 11/30, the Rules Committee denied a request by Rep. Louise Slaughter (D-NY) to add an 11th-hour amendment to the 21st Century Cures Act (see earlier story) that would have added an extra layer of adverse event reporting
Drugs
Adapt Pharma Operations has filed a citizen petition asking that FDA require sponsors of ANDAs for generic intranasal naloxone products to submit specific types of data to support the interchangeability of the generic version of its reference-listed product (Narcan). Specifically, the petition asks that FDA: * not approve a generic
Drugs
FDA has denied a Vanda Pharmaceuticals 9/7 petition asking that the agency not approve an ANDA referencing its atypical antipsychotic drug Fanapt (iloperidone) until expiration of a three-year exclusivity relating to Vanda’s clinical study of the drug for maintenance treatment of schizophrenia. The denial letter says the