Drugs
FDA has announced a 10/21 public meeting to hear public comments on the recent proposed agreement to reauthorize the generic drug user fee program. The draft agreement will be finalized and delivered to Congress in January. One major change in the draft is that review performance goals will be
Devices
FDA has cleared a Royal Philips 510(k) for the S4-1 cardiac transducer for Lumify, a“smart-device” diagnostic ultrasound solution. The pocket-sized and lightweight device offers high-resolution 2D image quality and exam pre-sets to allow clinicians to quickly triage and assess their patients, the company
Drugs
FDA has released a guidance on “ANDA Submissions — Prior Approval Supplements Under GDUFA” that is intended to assist applicants preparing such submissions. The document describes the agency’s performance metric goals for reviewing these and clarifies how it will handle submissions that fall under user fee performance metric goals.
FDA Policy/General
Federal Register Notice: FDA has announced the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2018. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has renewed the Antimicrobial Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2018. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Software as a Medical Device (SaMD): Clinical Evaluation.” The document was prepared under the auspices of the International Medical Device Regulators Forum, formerly the Global Harmonization Task Force. It focuses on the general principles of clinical evaluation, which includes
Devices
Leonhard Lang has begun a Class 1 recall of its multi-function defibrillation electrodes DF29N because they will not work with Welch Allyn’s automatic external defibrillator model AED 10. AEDs are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest. A recall notice says the electrodes
Drugs
FDA has told Egalet Corp. that it will not meet a previously announced 10/14 user fee review target date for the pain drug Arymo ER (morphine sulfate). The agency said the delay is centered on the product label, according to the company. “The FDA indicated that they need more
Devices
FDA has published an International Medical Device Regulators Forum guidance, Software as a Medical Device (SaMD): Clinical Evaluation, in an effort to establish a “common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of software intended for medical purposes” as defined in a
Devices
FDA has approved a Medtronic PMA for its cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla magnetic resonance imaging (MRI) machines. The approval covers the company’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators and
Drugs
FDA has accepted for review a Sunovion Pharmaceuticals NDA for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist delivered using PARI’s Pharma’s eFlow closed system nebulizer for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The agency has set
Drugs
Stakeholders are generally voicing support for two FDA draft guidances on compounded drug products that are essentially copies of a commercially available drug product. The Biotechnology Innovation Organization (BIO) says it strongly believes that the drug compounding provisions of the Drug Quality and Security Act did not change current law
Devices
FDA has updated a June safety communication calling attention to infections associated with Stӧckert’s 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) and to add steps that healthcare providers and facilities can take to mitigate patient risk. Over the past few months, the
Devices
Responding to an FDA draft guidance on use of standards in agency regulatory oversight of next generation sequencing-based in vitro diagnostics used for diagnosing germline diseases, the American Medical Association (AMA) reiterates its assertion that FDA lacks statutory authority to regulate any laboratory-developed tests, including those at issue,
Drugs
FDA has placed a clinical hold on an Aptose Biosciences Phase 1b clinical trial of APTO-253 in patients with hematologic cancers, requesting additional information. The agency is requesting the complete chemistry, manufacturing and control information for the final GMP drug substance and drug product intended for the clinic, according
Drugs
Some researchers are complaining the meta-analyses, which combine the results of many clinical studies in an effort to make it easier for doctors to keep up with research, are affected by conflicts of interest in those who do the analyses. A National Public Radio report quotes Stanford University professor
Drugs
FDA has granted Chromocell and Astellas Pharma a fast track designation for drug candidate CC8464/ASP1807 for managing neuropathic pain associated with idiopathic small fiber neuropathy. In 2015, the companies entered into a license and collaboration agreement for developing the product. Chromocell submitted an IND for CC8464/ASP1807 in July,
Drugs
Sen. Ed Markey (D-MA) says FDA “must not become complicit in the growing prescription fentanyl problem this country is combating.” In a letter to FDA commissioner Robert Califf, Markey particularly referenced Insys Therapeutics’ Subsys, which was approved by FDA in 2012 only for intense and persistent cancer pain. Markey
FDA Policy/General
FDA acting associate commissioner for special medical programs Janice Soreth, who is now chairing the FDA Safety and Innovation Act (FDASIA) Section 907 steering committee to increase clinical trial diversity, says progress has been made on nearly all of the action items the agency needed to take. Writing in an
Drugs
In response to increasing data integrity citations in Warning Letters and inspections, FDA has signed an agreement with CluePoints to develop a data driven software tool to detect data anomalies indicative of fraud, misconduct or sloppiness. Earlier this year, the agency released a draft guidance, Data Integrity and Compliance with
Devices
The Case for Quality, a collaboration between FDA, the medical device industry, healthcare providers, and quality experts, is examining the feasibility and effectiveness of using standardized medical device performance data and analytic techniques to help hospitals better compare and evaluate product quality. The multi-year Case for Quality initiative is
FDA Policy/General
Federal Register Final Rule: FDA has amended its regulations on the definition of a custom device to include new enumerated statutory requirements for such products. It amends the existing custom device exemption and introduces new concepts and procedures applicable to them. The amended definition states that a device will qualify