Drugs
As part of the Trump Administration’s opioid crisis plan, the president 3/19 warned pharmaceutical companies marketing opioid and other addictive pain killers that the Department of Justice is “looking very seriously into bringing major litigation against some of these drug companies.” Speaking at an anti-opioid addiction event
Devices
An 8/16-8/25/17 FDA inspection at Vilex in Tennessee, McMinnville, TN, found Quality System Regulation violations in the firm’s work as a specification developer and relabeler/repacker and conducting limited manufacturing operations for its Class 1 and 2 orthopedic implants and tools. A just-released 1/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Diamond Wipes International Chino, CA (3/7): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish written
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-LO Insert and Rotate Spacer System and its use in micro-invasive lumbar interbody fusion procedures. The device is available in PEEK material and is offered in 7-degree and 12-degree lordosis and multiple footprint options. It also
FDA Policy/General
Federal Register notice: FDA has extended by 60 days the comment period on a 12/20/2017 Federal Register notice entitled “Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on how to determine the number of employees for purposes of a “small business” definition. FDA allows certain exemptions for entities considered a “small business.” To view the notice, click here.
FDA Policy/General
Amazon has hired former FDA chief health information officer Taha Kass-Hout, a sign that the online retailing behemoth may be challenging Google and its X Lab in the health technologies race, according to a CNBC report. Kass-Hout has been quietly brought on at Amazon to serve in a
FDA Policy/General
Federal Register notice: FDA has announced a 6/11-12 public workshop on “Pathways to Global Unity.” The workshop is intended to provide information about agency drug and device regulation to regulated industries. To view the notice, click here.
Drugs
As House Republicans prepare to advance a right-to-try bill through the Rules Committee process, four former FDA commissioners have issued a brief joint statement opposing the measure. Issued by ex-FDA heads Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, the statement read: “We as former
Drugs
A new FDA drug approval transparency pilot program has released the first Clinical Study Report (CSR) which provides more background on why the agency recently approved Janssen Biotech’s Erleada (apalutamide), the first treatment for non-metastatic, castration-resistant prostate cancer. The drug was approved last month and it was
Drugs
FDA has accepted a pSivida Corp. NDA for Durasert three-year treatment for posterior segment uveitis. The agency has set a user fee review action target date of 11/5. The submission includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months.
Devices
FDA has cleared a Cook Medical 510(k) for the Cellvizio Confocal Laser Endomicroscopy System and the Confocal Miniprobes. “Additional data provided in multiple peer-reviewed medical journals paved the way for this new clearance and indication for the Cellvizio system,” the company says. With the clearance, the device can
FDA Policy/General
Arthritis Drugs Panel to Review Eli Lilly NDA Federal Register notice: FDA announces a 4/23 Arthritis Advisory Committee meeting that will review an Eli Lilly NDA for baricitinib tablets. 03/16/2018 Comments Sought on MedWatch Info Collection Federal Register notice: FDA seeks comments on an information collection extension
Drugs
FDA has approved a Tetra Discovery Partners IND for BPN14770, a novel, selective small molecule inhibitor of the phosphodiesterase type-4D enzyme. The company says its research suggests the drug may be useful in the treating Fragile X Syndrome and possibly other autism spectrum disorders. Tetra plans to initiate a
FDA Policy/General
Federal Register notice: FDA has announced a 4/23 g Arthritis Advisory Committee meeting. Panel members are scheduled to discuss an Eli Lilly NDA for baricitinib tablets, indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The
Drugs
FDA has approved CSL Behring’s Hizentra (immune globulin subcutaneous [human] 20% liquid) as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment. The approval was based on data from the Phase 3 PATH study, which demonstrated that the percentage of patients experiencing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “MedWatch: The FDA Medical Products Reporting Program” (OMB Control Number 0910-0291). MedWatch permits the reporting of adverse events, product problems, errors with the use of a human medical product, and evidence of therapeutic failure in clinical
FDA Policy/General
Federal Register notice: FDA has amended a 1/23 notice about a 3/22 Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting to reflect a change in the agenda for the open session of the meeting and to extend the amount of time allotted for the closed
Drugs
Q BioMed has filed with FDA for approval of a new manufacturing facility to make strontium chloride Sr89 injection USP, a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and osteoblastic
Drugs
Bayer has recalled Alka-Seltzer Plus packages that were sold at Walmart, CVS, Walgreens, and certain other stores in the U.S. Affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton. “This may lead consumers to ingest a
Drugs
FDA has issued the first report of generic drug quarterly metrics required under the GDUFA 2 user fee amendments. The report shows that at the end of the FY 2018 first quarter, there were 2,055 ANDAs awaiting FDA action. The mean full approval time was 41.7 months and
Drugs
FDA says it is delaying indefinitely the effective date of amendments to the existing medical product “intended use” regulations to give the agency more time to consider comments on the proposal. A Federal Register notice scheduled to be published 3/16 says the action does not delay the effective date