FDA Policy/General
Federal Register notice: FDA is withdrawing approval of three NDAs because the application holders have repeatedly failed to file required annual reports. The withdrawn NDA are: * NDA 016401: PolyMedica Industries’ Neopap (acetaminophen) suppositories * NDA 050266: Storz Ophthalmics’ Achromycin (tetracycline hydrochloride ophthalmic ointment, 10 mg/gram * NDA 050268: Storz Ophthalmics’ Achromycin
Biologics
Two retiring senior FDA vaccine officials, CBER Office of Vaccines Research and Review (OVRR) director Marion Gruber and her deputy Philip Krause, have joined outside researchers to argue against requiring Covid-19 booster shots until data can show a necessary benefit. Writing in a 9/13 Lancet viewpoint article, the
FDA Policy/General
Federal Register notice: FDA has announced an 11/4 Blood Products Advisory Committee meeting. Panel members are scheduled to hear three updates on the research programs at CBER’s Plasma Derivatives Branch, Laboratory of Cellular Hematology, and Laboratory of Emerging Pathogens. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is consolidating regulatory oversight responsibilities in CBER for certain devices that process autologous human cells, tissues, and cellular and tissue-based products at the point of care where the device output is intended to mediate the intended therapeutic effect. To support this consolidation effort, fat transfer
Drugs
FDA has posted a draft International Conference for Harmonization guideline entitled Nonclinical Biodistribution Considerations For Gene Therapy Products ICH S12. The document provides harmonized recommendations for conducting nonclinical biodistribution (BD) studies for developing gene therapy products. It provides recommendations for the overall design of nonclinical BD assessments, and considerations for
Devices
FDA has classified as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company due to a risk of bacterial contamination with Burkholderia cepacia complex. The affected products are distributed by a number of companies under various product names, including MediChoice Ultrasound Gel
Drugs
FDA has accepted for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy. The agency has set a user fee review action target date of 7/12/
FDA Policy/General
Allergenic Products Panel to Hear Research Overview 9/10/2021 Federal Register notice: FDA has announced a 10/28 Allergenic Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs in CBER’s Laboratory of Immunobiochemistry. To view the notice, click here. Workshop on
FDA Policy/General
DEVICES FDA has granted 510(k) clearance to Joimax to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF On-Cage implant. According to the company,the implant allows surgeons to use an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion, into the intervertebral disc, enabling endoscopic-assisted
FDA Policy/General
Federal Register notice: FDA has announced a 10/28 Allergenic Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs in CBER’s Laboratory of Immunobiochemistry. To view the notice, click here.
Drugs
FDA has granted Vor Biopharma a fast track designation for VOR33, Vor’s engineered hematopoietic stem cell therapeutic candidate for treating acute myeloid leukemia (AML). The therapy comprises CRISPR genome-edited hematopoietic stem and progenitor cells that have been engineered to lack CD33, according to the company. “Once infused, VOR33
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for public scoping on the environmental impact statement described in the notice entitled “Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use” that appeared in a 5/13 notice. Electronic or written comments
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has proposed a new study to examine whether disclosures in direct-to-consumer (DTC) and healthcare provider-targeted advertising could support allowing clinical benefit information based on a secondary endpoint reported in a product’s approved labeling (secondary claim) to be included
Drugs
FDA has announced a 9/23 symposium entitled “FDA-PDS Symposium X – Data Sharing; The Future of Clinical Trial Data Sharing…The Art of the Possible.” The meeting is intended to provide a forum for open discussion between leaders in oncology treatment and research and development from academia, government, and
Devices
FDA says it has initiated on-site inspections at Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements, following a recent Class 1 recall of its continuous and non-continuous ventilators due to concerns about the polyester-based polyurethane sound abatement foam, which is used to reduce sound and
FDA Policy/General
Federal Register notice: FDA has announced a public workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.” Convened by the Duke-Margolis Center for Health Policy, the workshop is intended to give stakeholders an opportunity to provide input on
FDA Policy/General
Former FDA commissioner Stephen Hahn has joined YourBio Health, described as the developer of the first painless pushbutton blood collection device, as its interim chief medical officer. Hahn is also the chief medical officer for the Preemptive Medicine and Health Security Initiative at Flagship Pioneering at large, according to a
Drugs
FDA has granted breakthrough therapy designation to Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin) for treating heart failure with preserved ejection fraction. An American Journal of Managed Care online post says Jardiance is the first drug in its class to gain the designation. The post says results from the EMPEROR
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products. The International Council for Harmonization document provides recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy products. It also offers considerations for interpreting and applying
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products. Comments can be submitted until 10/12. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications” (OMB Control Number 0910-0865). The collection allows FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test
Drugs
FDA has rejected a Humanigen emergency use authorization (EUA) request for the use of its lenzilumab in newly-hospitalized Covid-19 patients. FDA reportedly told the company it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as