Drugs
FDA has warned patients and healthcare providers about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (see listing below). In
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Bellus Medical, LLC. Dallas, TX (9/13). FDA inspected the firm in March and determined that it markets the SkinPen II device without having submitted a 510(k). FDA
Devices
FDA has approved a St. Jude Medical PMA for the BurstDR stimulation, a physician-designed spinal cord stimulation (SCS) for treating chronic pain. BurstDR stimulation “works differently from other stimulation designs, utilizing intermittent ‘burst’ pulses designed to mimic the body’s natural nerve impulse patterns,” the company says. Approval was
FDA Policy/General
Federal Register Notice: FDA has announced the withdrawal of 44 NDAs and 158 ANDAs from multiple applicants. The holders of the applications notified the agency that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. To view this notice, click here.
FDA Policy/General
Federal Register Final Order: FDA has published an order denying a petition requesting exemption from the premarket notification requirements for “method, metallic reduction, glucose (urinary, nonquantitative)”devices that are in a reagent tablet format and are currently classified as Class 2 devices. The devices are used in the diagnosis and
FDA Policy/General
Federal Register Notice: FDA has announced an information collection request extension related to a CVM guidance on “How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway.” The document outlines general standards to be used for the submission
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for a revised draft guidance on “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” that was originally released 8/12 in the Federal Register. Interested parties can submit either electronic or written comments by 12/12. To view this notice,
FDA Policy/General
Federal Register Notice: FDA has announced a public workshop entitled “Center for Devices and Radiological Health Veteran Amputee Devices” that seeks to engage stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal is to hear veteran amputees’ views on
Drugs
Lilly associate senior consultant for global quality laboratories Mark Newton says there is the potential for adverse pharmaceutical data integrity impact when companies uses a layered approach, such as a data entry forms layer, business rules layer, and database layer. Writing in an online blog post, Newton references a recent
FDA Policy/General
The Connecticut federal court has ruled that FDA’s procedures for expedited processing of Freedom of Information Act requests are legal. Attorney Jenifer Stach (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the case involved requests from Treatment Action Group, an independent AIDS research organization,
Devices
A 11/9-11/25/15 FDA inspection at Collagen Matrix in Oakland and Franklin Lakes, NJ, found that the firm’s Zcore porcine xenograft particulate in syringe device is adulterated because it doesn’t comply with Quality System Regulations covering current good manufacturing practice. A 9/20 Warning Letter
Drugs
FDA says it recently completed its 20th patient-focused drug development meeting held as part of the PDUFA 5 agreement. CDER Office of Strategic Programs director Theresa Mullin writes in an FDA Voice blog post that under PDUFA 5 FDA committed to obtain patients’ views in at least 20 disease
Drugs
FDA says that Nippon Fine Chemical Co., Takasago City, Hyogo, Japan, limited and/or refused an FDA inspection when an investigator came to the company on 12/14/15. A 9/15 Warning Letter says that under the Federal Food, Drug, and Cosmetic Act, drugs produced by the company are
Devices
The HHS Office of the Inspector General (OIG) says that FDA and the Centers for Medicare and Medicaid Services (CMS) recently took an important step when they co-signed a letter supporting capturing the device identifier (DI) portion of the unique device identifier (UDI) on claim forms for implantable devices.
Drugs
In its report on potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System between April and June, the agency says it is evaluating the need for regulatory action on 22 separate signals in products or classes of products. The report also shows action
Devices
A Kickstarter funding campaign launched by Tute Genomics to give consumers access to their personal genetic information has been postponed after receiving an FDA letter concerning its approach to marketing genome sequencing and analysis directly to consumers. In a note on Kickstarter, Tute Genomics CEO Reid Robison says that “after
Devices
CDRH says it is working with standards organizations, federal partners, professional societies, advocacy groups, patients and other stakeholders to reduce the chance of medical device misconnections, which may occur when one type of medical device is mistakenly attached to another device that performs a different function. “Because these connectors are
FDA Policy/General
Federal Register Notice: FDA has announced an 11/9-10 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting in Gaithersburg, MD. On 11/9, the panel will vote on the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from Class 3 (premarket approval) to Class 2 (510(k)
FDA Policy/General
Federal Register Notice: FDA and other government agencies announce an 11/8 public workshop on “Promoting Semantic Interoperability of Laboratory Data” to receive input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in
Devices
Baxter International has begun a recall of all unexpired lots of 50mm 0.2 micron filters (product code H93835) due to the potential for a filter support membrane to be missing and for the potential presence of particulate matter. “These issues are associated with a component manufactured by an external
Drugs
A new CDER drug safety report has outlined ongoing research priorities to improve drug safety. For example, one priority is to use electronic health care data to better determine suicide risks associated with approved drug products. “CDER must enhance its ability to determine if suicide is a potential adverse event
Drugs
FDA has denied a Haner & Kuo (New York) citizen petition, which was filed on behalf of an unnamed client, that asked FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. Like several others still pending at the agency, this petition