Devices
FDA has permitted the de novo marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands). The clearances were issued to Fluoptics for
Drugs
FDA has issued a draft guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs and biologics to treat chronic hepatitis B viral infection from IND through NDA/BLA and postmarketing. The document says it will be the focus for continued
Drugs
FDA says healthcare providers and patients should be aware that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the agency and may not have the scientific or clinical evidence to support such use for most medications. An agency safety
FDA Policy/General
Federal Register notice: FDA has classified the meprobamate test system into Class 2 (special controls). The action follows a 2/2017 de novo classification request from Lin-Zhi International for its LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay. The device is identified as being intended to measure meprobamate in human specimens.
Devices
FDA has permitted the de novo marketing of 23andMe’s Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The
FDA Policy/General
Federal Register notice: FDA has classified insulin therapy adjustment devices into Class 2 (special controls). The action follows a DreaMed Diabetes de novo classification request for its DreaMed Advisor Pro. Such devices are identified as intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to
FDA Policy/General
Federal Register notice: FDA is withdrawing two proposed medical device rules after determining that they are not currently considered viable candidates for final action. The withdrawal is part of the agency’s regulatory reform process. The two proposed rules that are being pulled are: a proposed amendment to the performance
Devices
The HHS Inspector General (OIG) says FDA should take steps to have its policies and procedures better address medical device postmarket cybersecurity risks. In a report, OIG says it conducted an audit because it had identified ensuring the safety and effectiveness of medical devices and fostering a culture of cybersecurity
Devices
FDA says it is evaluating recent reports of Getinge’s Maquet/Datascope intra-aortic balloon pump devices shutting down while running on battery power. A letter to healthcare providers says the devices are used on critically-ill patients in healthcare facilities, including during transport. “An interruption in treatment can result
Devices
FDA has cleared an OsteoRemedies 510(k) for the Remedy Spectrum GV Hip Spacer System and Spectrum GV Bone Cement, which are intended to provide surgeons with a broad-spectrum treatment option with both gentamicin and vancomycin. The device is indicated for temporary use (maximum 180 days) as an adjunct
Drugs
Heron Therapeutics has submitted an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for managing postoperative pain. The therapy was previously granted both Breakthrough Therapy and Fast Track designations. The submission is based
Devices
CDRH director Jeffrey Shuren says FDA is “confident that the current safety limits for cell phone radiofrequency energy exposure remain acceptable for protecting the public health.” Shuren issued a statement to comment on findings from research conducted by the National Toxicology Program that found “clear evidence” of carcinogenic activity in
FDA Policy/General
FDA has told the House Energy and Commerce Committee that the number of Office of Criminal Investigations (OCI) special agents assigned to Port of Entry (POE) duty doubled in August from six to 12. In addition, OCI added an import senior operations manager to oversee the program, and also added
Devices
Saying they are not currently considered viable candidates for final action, FDA is withdrawing two proposed medical device rules. An 11/1 Federal Register notice says that as part of its regulatory reform process, the agency reviews the backlog of proposed regulations that have not been finalized. The two proposed
Drugs
The DC Circuit Court of Appeals has ruled that FDA acted properly in denying a request for a hearing and withdrawing an ANDA submitted by Breckenridge Pharmaceutical and Nexgen Pharma for a generic version of Braintree Laboratories’ prescription MiraLax. The court opinion noted that after FDA approved Braintree’s NDA
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Bar Code Label Requirement for Human Drug and Biological Products” (OMB Control Number 0910-0537). In 2004, FDA issued a final rule that requires human drug product and biological product labels to have bar codes. Specifically, the
Devices
FDA has cleared an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrument. The new molecular test is intended to detect and differentiate herpes simplex viruses 1 and 2 nucleic acid isolated from swab specimens from
Devices
FDA has cleared a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain management. This clearance gives patients iPhone and Apple Watch mobile control over the company’s multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) System for chronic
Drugs
Former FDA associate commissioner Peter Pitts says the agency’s efforts to streamline drug approvals where safety reviews have shown positive results are starting to pay off. Writing in an online column in The Virginia Gazette, Pitts notes that in 2017 FDA approved more than 1,000 generic drugs, 200
FDA Policy/General
Federal Register notice: FDA has announced a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR). On 12/4, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. On 12/5, there will
Devices
University of Toledo Colleges of Engineering and Medicine professor Aakash Agarwal says FDA should stop clearing 510(k)s and approving PMAs for reprocessing of pedicle screws and other implantable orthopedic devices, and should stop clearing 510(k)s for reusable implantable orthopedic devices. A 10/31 petition describes in
Drugs
FDA says that SciGen is recalling specific lots of its hypertension medicine irbesartan for a potential cancer risk due to contamination. The agency says that the recalled lot will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label. A CNN story also discusses the recent recall of some drugs containing