Devices
FDA has classified as Class 1 a CareFusion recall of its Alaris Syringe Pump due to an alarm error which may cause therapy interruption. The infusion pump is intended to deliver fluids, such as nutrients, blood and medications, into a patient’s body in controlled amounts. A recall notice says
Drugs
FDA has approved Bio Products Laboratory’s Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for treating primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura in adults. Gammaplex 10% is made with the same process as the company’s previously approved Gammaplex 5%. The latest product, Bio Products says, is
Biologics
Sanofi says it will resubmit a joint BLA submission with Regeneron Pharmaceuticals for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. In October, FDA sent the companies a Complete Response Letter on their BLA, citing certain deficiencies identified during a
Devices
A 6/27-6/30/16 FDA inspection at Implant Dental Technology, Guangdong, China, found Quality System Regulation violations in the firm’s manufacturing of porcelain-fused-to-metal restorations, porcelain restorations, partial dentures, and full dentures. A just-released 10/25/16 Warning Letter says that violations included: * failing
Drugs
Vertice Pharma, which markets an FDA-approved potassium chloride oral solution, is asking that the agency refuse to receive drug applications seeking approval of certain potassium chloride drug products and refrain from approving any pending applications for such products that do not have a complete risk assessment and appropriate controls
Devices
Rep. Ted Lieu (D-CA) has introduced H.R. 872, the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 (DEVICE Act of 2017), “to enhance medical device communications and enhance device cleanliness.” The bill (text not yet available) would require medical device manufacturers to give advance
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Berkeley Nutritional Manufacturing Corp. Livermore, CA (1/31): FDA inspected the firm 2/2016 and documented serious GMP violations for dietary supplement products. FDA also found labeling violations for
Devices
FDA has cleared a Bioness 510(k) for the L300 Go System, intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and assist knee flexion or extension in those with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to
Drugs
The Federal Trade Commission (FTC) says in a federal court complaint that Shire ViroPharma violated antitrust laws by submitting multiple petitions to FDA and filing court suits against the agency to delay FDA approval of generic Vancocin HCl capsules. The complaint says that due to the company’s actions, consumers
Drugs
Three Arent Fox attorneys say that a Trump administration executive order requiring agencies to identify two existing regulations to be repealed for every new regulation they propose could cause delays in FDA efforts to implement provisions of the 21st Century Cures Act. Writing in an online blog post, the attorneys
FDA Policy/General
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) have written the White House Office of Management and Budget asking for additional guidance clarifying whether FDA is exempt from a hiring freeze ordered last month. The lawmakers, who played instrumental roles in drafting the 21st Century Cures law, are
FDA Policy/General
Federal Register Notice: FDA has delayed until 3/21 the effective date of its final rule on “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses,’” which published on 1/9. The rule is being reviewed
Drugs
FDA has lifted a partial clinical hold on a Northwest Biotherapeutics Phase 3 trial of its personalized immune therapy DCVax-L for glioblastoma multiforme brain cancer. The company says that the trial has “accumulated a sufficient number of events toward the progression-free survival (PFS) endpoint, but not yet for
Drugs
FDA has delayed the effective date of a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use.” The delay, according to an FDA notice, allows the Trump Administration to review and decide whether the rule should stay
Devices
A 5/9-5/12/16 FDA inspection at Neo Vision, Wonju-Si, Gangwon-Do, Korea, found violations of Quality System Regulations in the firm’s manufacturing of daily wear soft contact lenses. A just-released 9/14/16 Warning Letter says that violations shown on an FDA-483 included:
Drugs
Reps. Andy Biggs (R-AZ) and Brian Fitzpatrick (R-PA) have introduced the Right to Try Act of 2017, which would allow terminally ill patients an option to receive drugs that have passed FDA’s “basic safety testing but are still working their way through the often lengthy bureaucratic process
FDA Policy/General
Federal Register Notice: FDA is modifying the process by which it collects and post curricula vitae (CVs) of advisory committee members. The new process requires FDA to post CVs to its Web site without removing or redacting any information. Posting CVs without removing or redacting any information will increase panel
Devices
FDA has cleared an Elekta 510(k) for its Venezia applicator for gynecological brachytherapy in treating advanced-stage cervical cancer. Venezia received CE Mark approval in November 2016. “There is overwhelming clinical evidence that modern image-guided brachytherapy is an effective treatment modality for cervical cancer,” the company says. “Advanced
Drugs
Drug company executives prefer former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, as the candidate president Donald Trump should nominate for commissioner, based on a survey by Mizuho Securities USA. Gottlieb is a physician and fellow at the American Enterprise Institute whose commentaries frequently appears in
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months after neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The
Drugs
By lowering FDA regulatory standards as president Donald Trump promised pharmaceutical makers last week at the White House, many FDA watchers fear patients could be exposed to ineffective therapies until data gathered after marketing approval demonstrate effectiveness. Trump reportedly is considering several commissioner candidates that argue for quicker market access
Drugs
FDA has accepted for review an Intarcia Therapeutics NDA for ITCA 650 (exenatide) for treating Type 2 diabetes. If approved, the drug would become the first injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy, the company says. It is designed to provide consistent and continuous subcutaneous delivery