Biologics
FDA commissioner Stephen Hahn and CBER director Peter Marks say it is time that unproven and unapproved regenerative medicine products be identified and recognized as uncontrolled experimental procedures that can cost patients both physically and financially. Writing in the Journal of the American Medical Association, Hahn and Marks say that
Drugs
The FDA Oncology Center of Excellence has launched its Project Patient Voice Web site to create a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. In a statement, FDA says the patient-reported data have historically been analyzed by FDA during the
Devices
Hyman, Phelps & McNamara has asked FDA to provide examples to clarify specific items in the agency’s draft guidance on “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.” The draft guidance focuses on emergency-use injectors marketed with a drug/biological
Drugs
FDA has approved a Karyopharm Therapeutics supplemental NDA for Xpovio (selinexor), a selective inhibitor of nuclear export compound for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It was approved under FDA’s accelerated approval program. The drug first gained accelerated approval 7/2019 in
Devices
FDA has issued a safety alert on hand sanitizers manufactured by Eskbiochem SA de CV in Mexico due to the potential presence of methanol (wood alcohol), which can be toxic when absorbed through the skin or ingested. The alert identifies nine products manufactured by Eskbiochem that contain methanol. “Consumers who
Drugs
Senators Bob Casey (D-PA) and Susan Collins (R-ME) have introduced the Creating Hope Reauthorization Act (S 4010) that would permanently reauthorize FDA’s rare priority pediatric voucher program. The current voucher program is set to expire 9/30. The program has netted 22 novel therapies for seriously ill
FDA Policy/General
FDA’s Center for Veterinary Medicine has launched its Export Certification Application and Tracking System (CVM eCATS), a new online system that allows U.S. animal food, drug and device manufacturers to apply for, track and receive export certificates electronically for CVM-regulated animal products. Previously, CVM-regulated product makers
Devices
FDA has issued a guidance on “Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers.” The document says that CDRH is leveraging technology to host teleconferences and video conferences rather than in-person meetings with industry during the
Devices
FDA has updated a guidance entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency.” The document was updated to include a list of device types and corresponding product codes
Devices
[Report by David McFarland) FDA is learning fast that relaxing its standards during the Covid-19 pandemic causes many problems that it now struggles to contain and correct. The first troubles began with Covid-19 testing after FDA allowed testing laboratories and various manufacturers market access with minimal data and
FDA Policy/General
DEVICES FDA has approved an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The device uses magnetic detection during sentinel lymph node biopsy procedures to identify specific (sentinel) lymph nodes for surgical removal,
Devices
FDA has approved the expansion of a USGI Medical pilot study of it endoscopic procedure known as POSE 2.0. The study is designed to evaluate weight loss for adults suffering from obesity with a body mass index (BMI) of 35 to 40 kg and an obesity-related comorbidity, such
Drugs
Mylan says it is urging FDA to speed up its review of the company’s ANDA for a generic copy of Biogen’s multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) delayed release capsules, following a 6/18 northern West Virginia federal court decision that invalidated a Biogen patent. The current
Drugs
FDA has released a guidance entitled “Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug and Biological Products Manufacturing.” The document provides recommendations to drug and biological product manufacturers about manufacturing controls to prevent contamination of drugs, Covid-19 risk assessments as it relates to
FDA Policy/General
Federal Register notice: FDA has announced a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting. The panel is scheduled to discuss a GlaxoSmithKline BLA for belantamab mafodotin, indicated for treating adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38
FDA Policy/General
Federal Register notice: FDA is correcting a 2/12/2019 notice that announced the withdrawal of approval of 12 ANDAs from multiple applicants. That notice erroneously included ANDA 077736 for polyethylene glycol 3350 powder for oral solution held by Breckenridge Pharmaceutical. To view the notice, click here.
Devices
FDA has approved a 300 mg single-dose pre-filled pen for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab). The pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes at-home administration for atopic dermatitis, asthma and chronic rhinosinusitis with nasal
Drugs
FDA has approved an Evoke Pharma NDA for Gimoti (metoclopramide) nasal spray, indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The condition is associated with symptoms such as nausea, abdominal pain, bloating, early satiety, and vomiting which can be severe and debilitating, according to
Drugs
FDA has granted Ovid Therapeutics a rare pediatric disease designation to OV101 (gaboxadol) for treating Angelman syndrome. The company says that OV101 is believed to be the only delta-selective GABA receptor agonist in development and is currently being evaluated in the Phase 3 NEPTUNE trial, with topline results expected
Devices
FDA-backed Critical Path Institute’s (C-Path) Transplant Therapeutics Consortium (TTC) has submitted the iBox Scoring System for CDER’s Biomarker Qualification Program. TTC provided information supporting the qualification of the iBox Scoring System as a reasonably likely surrogate endpoint for clinical trials evaluating immunosuppressive therapies for use in
Devices
FDA says it is participating in the Covid-19 Diagnostics Evidence Accelerator, described as a multi-stakeholder project to advance the development of diagnostics. An online notice says the accelerator is organized by the Reagan-Udall Foundation in collaboration with Friends of Cancer Research. The notice says the Diagnostics Evidence
Drugs
FDA says it has published an update to the “List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic.” A statement says the list includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update, and for which FDA has