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
Drugs
FDA has granted EMD Serono a breakthrough therapy designation for its investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) that exhibit MET exon 14 skipping alterations and who have progressed following platinum-based cancer therapy. The designation was based on data showing that tepotinib
Devices
FDA has cleared a HeartFlow 510(k) for the HeartFlow Planner, a real-time virtual modeling tool for coronary artery disease (CAD) intervention. The device is intended to enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies for patients with CAD before each procedure, review
Drugs
Federal Register notice: FDA has announced an 11/14 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amarin Pharma supplemental NDA for Vascepa (icosapent ethyl) capsules for oral administration for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult
Drugs
A lengthy Bloomberg Businessweek report looks at the ongoing issue of N- nitrosodimethylamine (NDMA) contamination in the widely-used hypertension medicine valsartan. The contamination led FDA in 7/2018 to oversee a recall of drugs from three companies. There have been 51 additional recalls since then, including two additional drugs,
Drugs
An opinion column posted online by CNN says that a key source of the problem of high drug costs is abuse of the U.S. patent system. “Healthcare costs could be brought down through greater availability of generic drugs and biosimilars — drugs that are identical to branded drugs but distributed
Drugs
The FDA Allergenic Products Advisory Committee meets 9/13 to consider Aimmune Therapeutics’ BLA for Palforzia (peanut allergen powder) with a proposed indication to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis
FDA Policy/General
Federal Register notice: FDA has determined that Sanofi Aventis’ Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Calcimar if all other legal and regulatory requirements are met. To view the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Tsunami MedTech’s Aegea Vapor System, indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes in whom childbearing is complete. The review period is 1,
Drugs
Bayer says an FDA draft guidance on the content and format of instructions for use (IFU) for drug, biologic, and combination products “provides an opportunity to align with the previous effort by FDA to consolidate the current formats of patient labeling into patient medication information (PMI). The finalization of this