Drugs
FDA acting commissioner Janet Woodcock says she believes the nation’s clinical trial network might work best if drug companies remained more outside a revised network framework. In an interview printed online in Outsourcing Pharma, Woodcock says she has “always thought we should have independent people running the trial networks
FDA Policy/General
Federal Register notice: FDA has announced a 6/10 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss, in general, data needed to support authorization and licensure of Covid–19 vaccines for use in pediatric populations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 7/15 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to review a FibroGen NDA for roxadustat, a hypoxia inducible factor prolyl hydroxylase inhibitor for treating anemia due to chronic kidney disease in adult patients on or not on dialysis.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages. The document extends to 9/24/2023 the enforcement discretion date by which the agency does not intend to
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media. The document describes how the agency intends to evaluate requests for waiving the requirement
Devices
Medical Action Industries has recalled its Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator. The applicator was earlier recalled due to the risk of contamination with Aspergillus penicillioides. “If skin preparation products are contaminated with Aspergillus penicillioides, the fungus can cause serious systemic infection, sepsis, illness, and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” The document provides recommendations for covariate adjustment using nonlinear models. To view the notice, click here.
Drugs
FDA has issued a final guidance entitled Bispecific Antibody Development Programs that provides recommendations for specific regulatory, quality, nonclinical, and clinical considerations for such development programs. The document also clarifies quality, nonclinical, and clinical considerations when developing bispecific antibodies. The agency says that many aspects of a bispecific antibody development
Drugs
CDER says it will apply an intense focus to encourage the pharmaceutical industry to achieve “quality management maturity.” Delivering a Center update at the Food and Drug law Institute’s annual meeting 5/21, CDER director Patrizia Cavazzoni said that despite the overwhelming pandemic-related ongoing work, product quality remains
FDA Policy/General
Peripheral Vascular Atherectomy Devices 5/21/2021 Federal Register notice: FDA has made available a final guidance entitled Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions. The document provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. To view the notice, click here. More ANDA-
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances (XXX DELETE XXX)on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. It provides recommendations on the testing needed for assessing the safety and compatibility of medical devices in the magnetic resonance environment and the recommended format for
Devices
CDRH says it is undertaking research efforts to address scientific knowledge gaps in host responses to an implanted metal device, including adverse events, factors that help identify at-risk patients and tests or methods to better predict or identify exaggerated immune responses in patients. The research could also lead to
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Rybrevant (amivantamab-vmjw) for treating adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations — epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The agency also approved Guardant Health’s Guardant360 CDx as a companion
Devices
Boston Scientific has recalled its VICI SDS and RDS Venous Stent Systems after receiving reports indicating the devices may migrate or move from where they are initially implanted, according to a recall notice. “A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions. The document provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. To view the notice, click here.
Drugs
Federal Register notice: FDA has made available a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products. The document helps U.S.-regulated firms implement an International Council for Harmonization guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its annexes. It also includes
Devices
FDA has cleared an Overjet 510(k) for its Overjet Dental Assist product. The software device applies artificial intelligence (AI) in real-time to aid dentists and hygienists in measuring mesial and distal bone levels in bitewing and periapical radiographs for diagnosing and treatment planning of periodontal disease. In clinical
Drugs
FDA has accepted for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The agency set a 9/19 user fee action target date. The submission is based on data
Drugs
FDA’s adapting to the Covid-19 pandemic led to quicker and greater acceptance of real-world evidence, which has now led to the recognition that certain practices will be useful in this post-pandemic space. Speaking at the Food and Drug Law Institute’s annual meeting 5/20, CDER
Drugs
FDA has published a draft guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics, to provide recommendations for using covariates in the analysis of randomized, parallel-group clinical trials that apply to both superiority trials and non-inferiority trials. The document says its main focus is on
Drugs
FDA has published a draft guidance, Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions Statement of Investigator (Form FDA-1572) (Revision 1), describing how to complete FDA-1572 for clinical investigations conducted under IND regulations. The document partially revises a 5/2010 FDA-1572 FAQ (frequently