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
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,
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
FDA Policy/General
ANIMAL DRUGS FDA Amends Animal Drug Regs for Approvals, Etc. Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July and August. FDA has also made available approval summaries and environmental
FDA Policy/General
Federal Register Notice: FDA has announced the fee rate of $2.7 million for using a tropical disease priority review voucher for fiscal year 2017. The vouchers are awarded to sponsors of certain tropical disease product applications, submitted after 9/27/2007, upon FDA approval of such applications. To view
FDA Policy/General
Federal Register Notice: FDA has announced the fee rate of $2.7 million for using a rare pediatric disease priority review voucher for fiscal year 2017. The vouchers are awarded to sponsors of rare pediatric disease product applications that meet all of the requirements of the program and were submitted
FDA Policy/General
Federal Register Final Order: FDA has classified the Evoked Photon Image Capture Device into Class 1 (general controls). The device is identified as a prescription, electrically-powered device intended for use as a non-invasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are
FDA Policy/General
Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July and August. FDA has also made available approval summaries and environmental review documents. Additionally, the animal drug regulations have been amended
FDA Policy/General
A 9th Circuit Court of Appeals decision appears to “impermissibly grant FDA authority to regulate the practice of medicine and to further muddy the regulatory morass governing off-label use of products,” according to attorneys Anne Walsh and Andrew Hull (Hyman, Phelps & McNamara). Writing in their firm’s FDA
FDA Policy/General
Federal Register Notice: FDA has announced an opportunity for public comment on information collection related to an extension of “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” The collection pertains to records of personnel practices, including training documentation; records of
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/13 notice on the availability of a guidance on “Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The notice was corrected to
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/19 notice on “Biosimilar User Fee Act; Public Meeting.” The document was published with the incorrect date of the closure of the docket, which now reads 10/28/2016. To view this notice, click here.
FDA Policy/General
The Government Accountability Office (GAO) says its review of security controls over seven key FDA information systems found “a significant number of security control weaknesses [that] jeopardize the confidentiality, integrity, and availability of its information and systems.” The GAO report says that FDA did not fully or consistently implement access
FDA Policy/General
FDA should ban the use of triclosan in toothpaste, as it did in hand soaps earlier this month, according to the Cornucopia Institute. In a 9/29 letter to FDA, the group says FDA should take this action because triclosan is an endocrine disruptor. “Specifically, it disrupts thyroid, testosterone, and
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for a Medicines Company NDA for Ionsys (fentanyl iontophoretic transdermal system) that applies to a patent extension for the product. The agency determined that the applicable regulatory review period for the drug is 4,835 days. To view this notice,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ajes Pharmaceuticals, LLC. Copiague, NY (9/09). FDA inspected the firm’s dietary supplement facility and found serious GMP violations. For example, the firm failed to establish product specifications
FDA Policy/General
A recent 2nd Circuit Court of Appeals decision in a false advertising case explains the distinction between an advertisement that is literally false by implication and one that is impliedly false. Attorney Sandra Edelman (Dorsey & Whitney) writes in an online blog post that the decision involved a suit brought
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/19 notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (10/2007 to 12/2015).” The notice established a docket to receive suggestions, recommendations, and comments from interested parties
FDA Policy/General
Federal Register Notice: FDA has announced a public meeting to discuss proposed recommendations for reauthorizing the Generic Drug User Fee Amendments of 2012. The legislative authority expires 9/30/2017. The public meeting will be held 10/21 at FDA’s White Oak campus (Silver Spring, MD). To view this
FDA Policy/General
FDA associate deputy commissioner for medical products and tobacco Rachel Sherman has been promoted to deputy commissioner for medical products and tobacco, which was commissioner Robert Califf’s position before being confirmed as the agency head in February. Sherman had retired from the agency in 2014 and subsequently joined Greenleaf
FDA Policy/General
BIOLOGICS FDA has approved Amgen’s Amjevita, a biosimilar copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. This is FDA’s fourth approved biosimilar. DEVICES FDA has approved a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System. The device combines two technologies