Drugs
FDA has released a revised guidance on “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission types. It also references
Drugs
A drug supply chain security pilot program, which was approved by FDA in 2019, is endorsing blockchain technology to meet Drug Supply Chain and Security Act (DSCSA) requirements for an interoperable, confidential change-of-ownership system for the U.S. pharmaceutical supply chain. Last year, FDA began accepting pilot project
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 15 ANDAs from multiple applicants after notifying the agency that they are no longer marketed. To view the notice, click here.
Devices
FDA has approved a Flowonix Medical PMA for the Prometra II Programmable Pump System for an expanded use with intrathecal baclofen. Flowonix began marketing the 40mL pump 11/2019, providing patients and clinicians a choice between 20 mL and 40 mL capacities when choosing an intrathecal pump delivery device. The
Devices
FDA has cleared a KinetiCor 510(k) for the KinetiCor Motion Correction System and its use with Siemens Magnetom Skyra 3T MRI scanner. KinetiCor is cleared as an accessory to the Skyra scanner, and it uses sensor-based technology to track patient movement during an MRI session. “It helps provide
Drugs
FDA has issued a final rule and question and answers for patients and healthcare providers to ensure a smooth 3/23 regulatory transition that the agency says is aimed at increasing patient access to insulin products. As of 3/23, an online statement says, an application for a biological product
FDA Policy/General
A news column in The Lancet Respiratory Medicine synthesizes several recent studies showing that many companies fail to meet their obligation to report clinical trial results to ClinicalTrials.gov within a year of the trial’s completion. Although those who fail to report can be fined more than $10,000/
FDA Policy/General
FDA’s large-scale and ambitious plan to modernize its information technology (IT) use will not be seeing any increased funding under the fiscal year 2020 budget, FDA principal deputy ommissioner Amy Abernethy acknowledged 2/19 during an Alliance for a Stronger FDA Update. She said that the current budget
Devices
FDA says the Teleflex Medical 12/13/19 recall of its Comfort Flo humidification system is Class 1. The recalled units were manufactured between 10/1/14 and 6/30/19 and were distributed between 10/1 and 10/31/19. Some 398,320 devices were recalled in the U.
Drugs
FDA has granted priority review to a BioMarin BLA for its investigational AAV5 gene therapy (valoctocogene roxaparvovec) for adults with hemophilia A. This is the first time FDA has accepted a marketing application for gene therapy for any type of hemophilia. The PDUFA action date for the BLA is 8/
Drugs
FDA has approved a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain, alone or in combination with other analgesics. The product is intended to be administered as a once-a-day intravenous bolus push. The active ingredient meloxicam is a long-acting, preferential COX-
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/20/2019 notice seeking comments on “Guidance for Industry #256 — Compounding Animal Drugs from Bulk Drug Substances.” Comments can be submitted until 6/17. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.” The document expands upon recommendations on nonclinical immune system assessments provided in multiple other guidances, such as the International Conference on Harmonization’s “S8 Immunotoxicity Studies for Human
Drugs
Bristol-Myers Squibb says that a Phase 2 trial testing the combination of Five Prime Therapeutics’ cabiralizumab and Opdivo (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. A Five Prime statement says that the trial enrolled some 160 patients with locally
Devices
Researchers from three universities say that FDA was late in removing mesh implants for pelvic organ prolapse repairs “despite the numerous safety warnings and adverse events reported from patients’ narratives.” Writing in Obstetrics and Gynecology, the researchers say that the factors that prevented timely response to an FDA warning first
Drugs
CDRH and CDER say they are collaborating on an effort to provide FDA’s view of the state of the current science in pharmacogenetics. They are launching a Web-based resource that includes a table describing “some of the gene-drug interactions for which the agency believes there is sufficient
Drugs
Sen. Charles Grassley (R-IA) has predicted that his bipartisan Prescription Drug Pricing Reduction Act of 2019 will pass by 5/20. The Daily Iowan reports that Grassley addressed a healthcare summit in Coralville, IA, 2/14 and predicted the 5/20 passage. “The reason that’s an important date
Drugs
FDA has published a draft guidance, Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics, to assist sponsors by supplementing the recommendations on nonclinical immune system assessments provided across a number of International Council for Harmonization and FDA guidances. The document covers the evaluation of functional, histomorphologic, and
Drugs
Former FDA attorney William McConagha has moved from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation and enforcement practice partner in Washington, DC. After spending 17 years at FDA, McConagha joined Sidley in 2012 as a partner. At FDA, McConagha served in various positions, including
FDA Policy/General
Federal Register notice: FDA has announced a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta, a fixed-dose combination (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) oral inhalation for reducing all-cause mortality in patients with chronic
FDA Policy/General
Federal Register notice: FDA has announced a 4/23 Medical Imaging Drugs Advisory Committee meeting. Panel members are set to discuss an Avid Radiopharmaceuticals NDA for of flortaucipir F18 intravenous injection, a radioactive diagnostic agent for positron emission tomography brain imaging to estimate the density and distribution of aggregated tau
Drugs
FDA has denied a 2/2/19 petition submitted by a Philadelphia law firm asking that the agency ensure that all manufacturers of methscopolamine bromide tablets adhere to the agency’s 2016 Botanical Drug Development guidance and take enforcement action against non-compliant manufacturers. The agency response says that FDA