Drugs
FDA has released the FDA-483 issued following a 5/29-6/19 FDA inspection at Stokes Healthcare, a Mount Laurel, NC, outsourcing facility. Specific inspection observations were: * testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and
Drugs
Four drug industry stakeholders have provided detailed responses to an FDA request for comments on exposure-analysis in drug development and regulatory decision making. Pfizer suggests that the updated exposure-response guidance primarily focus on “what” and “why” elements and advance the 2003 version by citing illustrative examples that have
Devices
FDA has cleared a RedDress Ltd 510(k) for its RD1 system, a device that allows health care providers to produce in real time in vitro whole blood clots for use in wound care. “Under the supervision of a healthcare professional, the whole blood clot produced by the RD1 System
Drugs
President Trump has his sights on the drug industry after the latest round of price increases on dozens of products. In a 7/9 tweet, the president said: “Pfizer & others should be ashamed that they have raised drug prices for no reason. They are merely taking advantage of the
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the letter. Zhuhai United Laboratories Guangdong, China (6/27): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For
Devices
FDA has cleared a Visura Technologies 510(k) for its TEE Camera Assist Device, a single-use disposable camera that attaches to a transesophageal echocardiogram (TEE) ultrasound probe allowing physicians to view the upper airway and esophagus during probe placement for safe intubation. Physicians currently place TEE probes blindly, guided
FDA Policy/General
Federal Register notice: FDA has announced an 8/7 Antimicrobial Drugs Advisory Committee meeting. Panel members will discuss an Insmed NDA for amikacin liposome inhalation suspension, indicated for treating nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen. To view
Drugs
FDA has published a draft guidance, Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products—Content and Format, to assist applicants in drafting the Indications and Usage section of labeling for human prescription drug and biological products. The document’s recommendations include general principles to consider
Devices
CDRH director Jeffrey Shuren says the agency has led a working group of regulators from several countries under the auspices of the International Medical Device Regulators Forum (IMDRF) to establish basic policies for a new, pragmatic, and internationally harmonized regulatory framework for software as a medical device (SaMD) that better
Drugs
The 6th Circuit Court of Appeals says a lawsuit alleging failure of a generic drug company to provide a Medication Guide with a prescription for the anti-arrythmia drug amiodarone is preempted by federal law. Attorney Michelle Yeary (Reed Smith) writes in an online blog post that this was the
FDA Policy/General
FDA 7/3 posted the latest batch of Warning Letters while FDA Webview was closed for its annual holiday break. They can be accessed by clicking on the link following each letter. Foshan Jinxiong Technology Foshan City, China (6/26): FDA inspected the firm 8/2017 and cited significant GMP
Drugs
Fagron Sterile Services has recalled two lots of neostigmine methylsulfate 5ml syringes after a confirmed customer complaint that some syringe units are incorrectly labeled as neostigmine methylsulfate 1mg/ml, 3mg per 3ml. “In the event that 5ml rather than the intended 3ml is administered to a patient, adverse events from
Drugs
Drawing from a Science article, The BMJ says the FDA drug approval process “may be tainted by financial conflicts of interest with drug companies that are based not only on present and past ties, but also on future ones that may be created. The BMJ’s post says the Science
Drugs
A 10/23-10/27/17 FDA inspection at Sichuan Friendly Pharmaceutical Co., Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/22 Warning Letter says the specific deviations were: * failing to ensure that all specifications and test procedures are scientifically
Drugs
Two Hyman, Phelps, and McNamara attorneys say the Justice Department (DoJ) is quietly implementing a policy asking that various law enforcement entities appropriately coordinate in imposing penalties on a company, to “avoid the risk of repeated punishments that may exceed what is necessary to rectify the harm and deter future
Devices
FDA has cleared an IsoRay 510(k) for its GammaTile brachytherapy technology that uses proprietary Cesium-131 seeds within customizable collagen-based carriers for treating recurrent brain tumors. The therapy “leverages Cesium-131’s unique ability to deliver a highly targeted dose of intense radiation treatment while limiting radiation exposure
Drugs
Rep. Frank Pallone (D-NJ), ranking Democrat on the House Energy and Commerce Committee, says the committee should hold a hearing to examine misuse of the FDA Risk Evaluation and Mitigation Strategies (REMS) program by drug companies looking to block, impede, or delay generic competitors from coming to market. In
Drugs
FDA has cleared an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular degeneration (AMD). The device is designed to detect and characterize central and paracentral metamorphopsia (visual distortion) in patients with macular conditions including AMD and diabetic retinopathy. After
Drugs
An 8/15-8/18/17 FDA inspection at Foshan Jinxiong Technology, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 6/26 Warning Letter. Specific violations noted in the letter, were: * failing to have, for each batch of drug
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” The document’s recommendations are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible,
FDA Policy/General
Federal Register notice: FDA is seeking comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications” (OMB Control Number 0910-0719). The collection is related to the Biologics Price Competition and Innovation Act of 2009 that amended the Public Health Service Act and other statutes
FDA Policy/General
DEVICES FDA has approved Bausch + Lomb’s Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear. The contact lenses include the company’s MoistureSeal technology, a patented combination of material and manufacturing process that helps to maintain 95% of lens moisture for