Devices
FDA says it is amending regulations to reflect changes enacted into law by the 21st Century Cures Act. A Federal Register notice says that certain requirements related to humanitarian device exemptions (HDE) and institutional review boards (IRB) for devices have changed. The changes are: * allowing for HDE approval for devices
Drugs
Amgen’s suit against FDA over the agency’s denial of six months’ pediatric exclusivity for the company’s Sensipar (cinacalcet) tablets has been placed on hold by a DC federal court judge while the company seeks resolution of its claim through the FDA formal dispute resolution process. Attorney Kurt
Drugs
FDA says its review of Prestige Brand Holdings’ listings for PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s Plus Flu products contain inaccurate information. An agency 6/1 Warning Letter says the company must take prompt action to correct the deficiencies. According to the letter, the active
Drugs
A 5/23-5/26/16 FDA inspection at Yusef Manufacturing Laboratories found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/25 Warning Letter from the agency’s Los Angeles District Office. Specific violations noted in the letter were: * failing to thoroughly
Drugs
Acorda Therapeutics says it plans to file an NDA by the end of the month for CVT-301 (levodopa inhalation powder) after Phase 3 data showed a statistically significant, clinically meaningful improvement in motor function in Parkinson’s patients experiencing OFF periods. The company says OFF periods refer to the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Herbal Doctor Remedies Monterey Park, CA (5/25): FDA inspected the firm 11/2016 and reviewed product labeling/claims and determined that its herbal products are unapproved drugs. The
Devices
FDA says the Magellan Diagnostics recall of all lots of its LeadCare and LeadCare II blood lead testing systems manufactured between 9/2013 and the present and distributed between 1/1/14 and 5/22/17 is a Class 1 recall. The company expanded its LeadCare Plus and Ultra Testing
Drugs
Two CDER staffers from the Office of Compliance and Office of Pharmaceutical Quality discussed the Center’s expectations for data integrity and compliance with CGMP at the Society of Quality Assurance annual meeting. They said that 2016 enforcement actions, not including compounding-related action, involved 47 import alerts, 4 Untitled
FDA Policy/General
FDA’s former associate chief counsel for enforcement Peter Leininger has joined King & Spalding as counsel in its FDA and life sciences practice. With the agency, Leininger dealt with criminal investigations and prosecutions dealing with FDA-regulated products and assisted the Office of Criminal Investigations in gathering and evaluating
Devices
FDA has cleared a Clarify Medical 510(k) for the Clarify Medical Phototherapy System, a light therapy device for treating diseases such as psoriasis, vitiligo, and eczema. The company says its proprietary technology is designed to allow patients with chronic skin diseases to receive ultraviolet B phototherapy in their homes,
Devices
Bristol-Myers Squibb and Qiagen have entered into an agreement to explore using next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with BMS’ novel immuno-oncology (I-O) therapies in cancer treatment. The companies also plan to enter into a
Devices
FDA has approved a Roche PMA supplement for the cobas CMV (cytomegalovirus) test for use on its automated cobas 6800 and cobas 8800 Systems. The test provides healthcare providers with information to assess how transplant patients on therapy are responding to treatment. “The test is standardized to the 1st WHO
Drugs
CEL-SCI Corp. has responded to FDA about a clinical hold placed on the company’s Phase 3 head and neck cancer study with Multikine (leukocyte interleukin injection). The response addressed the study’s investigator brochure and a “Dear Investigator” letter, which were revised based on earlier FDA comments. The
Devices
FDA has allowed the de novo marketing clearance of Claret Medical’s Sentinel Cerebral Protection System to protect against the risk of stroke by capturing and removing debris dislodged during transcatheter aortic valve replacement (TAVR) before it reaches the brain. The clearance was based on data from the pivotal SENTINEL
Devices
FDA has approved an expanded indication for Edwards Lifesciences’ Sapien 3 Transcatheter Heart Valve for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high. “For the first time, a regulatory
Drugs
A just-concluded inspection of Strides Shasum Ltd. in Bangalore, India has resulted in a three-item Form-483 citing GMP deficiencies concerning finished pharmaceuticals. For example, the agency said the firm conducted manufacturing investigations but did not arrive at a root cause to take corrective actions. Additionally, FDA found
Biologics
Amgen has submitted a supplemental BLA for Repatha (evolocumab), a PCSK9 inhibitor, based on a cardiovascular outcomes study (FOURIER) which the company says showed that “maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible with the current best therapy alone, leads to a further
Devices
FDA has approved Inspire Medical Systems’ next generation Inspire 3028 implantable pulse generator for treating obstructive sleep apnea (OSA). The implantable device’s approval also covers magnetic resonance imaging conditional labeling to allow patients to undergo such testing. The Inspire 3028 is 40% smaller and 18% thinner than the current
Drugs
Public Citizen and 12 other patient advocacy groups are urging House Energy and Commerce Committee members to reject two bills that would “undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.” In a 6/5 letter, the groups argue that HR
FDA Policy/General
FDA commissioner Scott Gottlieb has brought on three former Capitol Hill staffers as part of his team of advisors. John Martin has been appointed principal associate commissioner for legislation. He previously served as legislative director for Senator Tom Cotton (R-AR). Martin will advise the commissioner on legislative activities and
Devices
CDRH says it intends to extend the compliance dates for the unique device identification (UDI) system requirements for low-risk medical devices (certain Class I and unclassified devices), such as manual surgical instruments and mechanical wheelchairs. The Center and industry have already implemented requirements for higher-risk medical devices (Class
Devices
Abbott has begun a Class 1 recall of its Absorb Bioresorbable Vascular Scaffold system, a temporary scaffold indicated for improving coronary luminal diameter. The company says it is recalling the device after studies showed elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients