Drugs
FDA has posted a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspection of the drug outsourcing manufacturer. For example, the company’s procedures designed to prevent microbiological contamination of its drug products did not include adequate validation of the aseptic
FDA Policy/General
Federal Register notice: FDA is seeking comments on a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. The devices are battery-powered tables with wheels that are intended for use by patients who are unable to propel themselves independently and who must maintain a prone or
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of an Impax ANDA for ursodiol capsules USP, 300 mg. Impax requested the withdrawal based on FDA’s concerns about the validity of bioequivalence data from an undisclosed contract research organization. Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones
Drugs
Former FDA Commissioner Scott Gottlieb has been appointed to the FasterCures advisory board. As a board member, Gottlieb will “leverage decades of experience to provide counsel to the FasterCures team in a variety of areas, including how to best engage patients in research, creating new pathways to innovation through novel
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device. The company says that traditional knotted meniscal fixator repair devices typically use hard plastic anchors and surface knots that can damage cartilage. The JuggerStitch device offers an all-suture, knotless approach to meniscal repair, Zimmer
FDA Policy/General
Guide on Special 510(k) Program Federal Register notice: FDA makes available a final guidance entitled “The Special 510(k) Program.” 09/13/2019 FDA Posts 9 OMB-approved Info Collections Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB. 09/13/
FDA Policy/General
Mylan says it will acquire Meda AB in a $7.2 billion cash-and-stock deal. This was the third attempt by Mylan to buy the Swedish company.The offer, recommended by Meda’s board, valued the company at $9.9 billion, including debt. RedHill Biopharma has submitted to FDA
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “The Special 510(k) Program.” The document provides the framework that FDA uses when considering whether a premarket notification 510(k) is appropriate for review as a Special 510(k). To view the notice, click here.
Drugs
Concerns about an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has now spread to some ranitidine heartburn drugs, including the brand-name drug Zantac, according to an FDA safety alert. The agency says that a nitrosamine impurity called N-nitrosodimethylamine (NDMA), which has been detected
Drugs
FDA says it will develop bioanalytical “best practices” for biosimilar biological product development. Writing in the recent American Association of Pharmaceutical Scientists Journal, a team of CDER officials said they examined 28 biosimilar biologic license applications that had been submitted up to 12/2018, which showed a “diversity of the
Drugs
FDA is warning that Pfizer’s Ibrance (palbociclib), Novartis’ Kisqali (ribociclib), and Eli Lilly’s Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause a rare and severe inflammation in the lungs. “We have approved new warnings about this risk to the prescribing information and patient
Drugs
KRS Global Biotechnology has recalled all lots of unexpired human and animal drugs due to sterility concerns. “Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening,” a recall notice (XXINSRT LINKXXX) says. The company says it
Devices
FDA says Sterigenics contract sterilization facility in Atlanta, GA is temporarily closed while it undergoes construction to reduce ethylene oxide emissions. The agency says that it is evaluating the impact it could have on medical device availability and it is communicating with any medical device companies that may be impacted.
Devices
FDA has cleared a Qfix 510(k) for the Encompass 15-Channel Head Coil, a diagnostic imaging device for use with the Encompass MR SRS Immobilization Device. The device provides diagnostic quality images for select Siemens 3T MRI Scanners. The adjustable geometry, 15-channel coil allows users to locate the
FDA Policy/General
Federal Register notice: FDA has released a list of information collections that have been approved by OMB. They are: * Disease Awareness and Prescription Drug Promotion on Television * Reporting Associated with New Animal Drug Applications and Veterinary Master * Substances Generally Recognized as Safe: Notification Procedure * Establishing and Maintaining Lists of U.
Devices
FDA has classified as Class 1 an Allergan July recall of its Biocell textured breast implant products (see story). The recall also included tissue expanders used by patients before breast augmentation or reconstruction. The recall was requested by FDA to address what it described as protecting women from breast implant-
Devices
FDA has published four guidances relating to aspects of the 510(k) pathway for medical devices. The first, The Special 510(k) Program, gives the agency’s current thinking on 510(k)s that are appropriate for review as a Special 510(k). The document says it describes an optional
Devices
FDA has given 510(k) clearance to the GE Healthcare Critical Care Suite, a collection of artificial intelligence algorithms embedded on a mobile X-ray device. The company says the algorithms help to reduce the turnaround time it can take for radiologists to review a suspected pneumothorax. The suite is
FDA Policy/General
Federal Register notice: FDA has announced a 10/7 Science Board advisory committee meeting. The panel is scheduled to hear a response from CBER to the recommendations made by the Science Board’s review of its research program. The Science Board will also discuss whether there are any relevant published
FDA Policy/General
Federal Register notice: FDA has announced an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection not responsive to standard therapies. FDA will consider scientific data and other information from the hearing to consider ways to support FMT
Drugs
Researchers from several universities around the world say that the size of therapeutic effects in alternative methods of FDA evaluation of breakthrough therapy drugs correlates with FDA approval without requiring randomized clinical trials. Writing in an open access article posted online, the researchers say the magnitude of treatment effects was
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Edwards Lifesciences’ Pericardial Aortic Bioprosthesis, indicated for replacement of native or prosthetic aortic heart valves. The review period is 1,858 days, which includes 1,491 days that occurred during the testing phase and 367