Drugs
FDA and the Reagan-Udall Foundation are creating a “central repository or clearinghouse” where useful and relevant information on the expanded access process could be stored in one place — a “one-stop-shop” for physician and patients, according to a blog post by CDER deputy director for science operations Richard
Biologics
FDA has withdrawn a 6/2-published Federal Register notice that sought Office of Management and Budget approval on an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Medical Device Accessories,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice,
FDA Policy/General
Federal Register Notice: FDA is making available a final guidance entitled Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff. It explains the circumstances in which it may be appropriate to extrapolate existing medical device data to support
Devices
A Health Affairs blog article suggests that FDA take a similar regulatory approach to the one it uses to oversee hearing aids for the emerging market of mobile health apps and wearables. For hearing aids, a product may be unregulated (e.g., personal sound amplification products) or regulated as a
Devices
FDA has granted Hologic an emergency use authorization for its new diagnostic assay for Zika virus infection, the Aptima Zika Virus assay. The molecular diagnostic tool allows for the qualitative detection of RNA from Zika virus in human serum and plasma specimens, according to the company. The assay runs on
Drugs
FDA has granted Fate Therapeutics a fast track designation for ProTmune for reducing the incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). The company says it is currently investigating ProTmune in an open-label Phase 1/2 clinical trial that
Devices
FDA has released a final guidance on “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices” that seeks to provide clarity and predictability for device sponsors on specific criteria that should be considered when deciding whether leveraging existing clinical data to support pediatric claims is appropriate. When
Biologics
CDER plans to release biosimilar guidance documents by the end of the year on statistical considerations for analytical similarity data, and interchangeability data standards, according to CDER associate director for therapeutic biologics Leah Christl. Speaking at a 6/20 Alliance for Health Reform biosimilar briefing, Christl said that the science
Drugs
FDA has approved a Sangamo BioSciences IND for SB-913, a zinc finger nuclease (ZFN)-mediated approach designed as a single treatment with the potential to provide a long-lasting therapy for Mucopolysaccharidosis Type II (MPS II, Hunter syndrome). The company is planning a Phase 1/2 clinical trial to
Devices
FDA has approved a Medtronic IDE for a pivotal study called SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy). The study is designed to support the expanded indication of currently marketed Visualase MRI-Guided Laser Ablation Technology for treating epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE)
FDA Policy/General
BIOLOGICS Panel to Discuss Amgen’s Humira Biosimilar Federal Register Notice: FDA will hold a meeting of the Arthritis Advisory Committee 7/12, from 7:30 a.m. to 5 p.m. at : FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503)
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. It provides recommendations on the submission of chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified
FDA Policy/General
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations. They provide product-specific guidance on the design of BE studies to support ANDAs. The products include amcinonide, cobimetinib fumarate, selexipag, and tacrolimus. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Quality Attribute Considerations for Chewable Tablets. It describes the agency’s thinking on the critical quality attributes that should be assessed when developing a chewable tablet dosage form and recommends that the selected acceptance criteria be appropriate
Drugs
In another setback for the Obama Administration’s get-tough crackdown on FDA-regulated company executives in fraud cases, a jury in Boston federal court has acquitted former Warner Chilcott president W. Carl Reichel of conspiring to pay kickbacks to physicians. The case stemmed from an earlier government investigation that
Devices
Ariad Pharmaceuticals has submitted an NDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, seeking approval for use in patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. FDA earlier granted the therapy breakthrough therapy and orphan drug designations for this patient population. The
Devices
FDA has cleared a REBIScan 510(k) for the Pediatric Vision Scanner, a handheld device designed to help physicians screen for amblyopia (lazy eye) and strabismus (misaligned eyes) in young children, as early as preschool age when the condition is easiest to treat. Amblyopia and strabismus are the leading cause
Drugs
FDA has accepted for review an Emergent BioSolutions supplemental BLA seeking approval to make BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (building 55). “Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses
Devices
FDA has released a draft guidance on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” that provides recommendations to improve the quality, consistency and transparency of data on how medical devices perform within specific age, race, and ethnic groups. “Proper evaluation and reporting of
Biologics
NIH’s Recombinant DNA Advisory committee (RAC) will meet 6/21-22 to review a protocol involving the first-in-human use of gene editing via CRISPR/Cas9 technology. According to a NIH Office of Science Policy post, the T cell immunotherapy protocol involves the use of CRISPR/Cas9 to