FDA Policy/General
Federal Register notice: FDA is posting notice that a BLA applicant for a biosimilar product has notified the agency that an action for patent infringement was filed in connection with the applicant’s BLA. FDA is required to publish notice of any complaint received under Section 351(l)(6)(C)
FDA Policy/General
What had seemed like an easy-to-confirm nomination of Robert Califf to be FDA commissioner, based on the 89-4 confirmation vote he received in 2016 when he served as commissioner in the Obama administration, is now stalled in a closely divided Senate and may not succeed. That’s
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Generic Drug User Fee Program” (OMB Control Number 0910-0727). The collection is being revised to include the current generic drug user fee agreement, or ‘‘goalsletter,’’ as reflected in the document “GDUFA Reauthorization Performance Goals and Program
FDA Policy/General
Federal Register notice: FDA is debarring for five years Brenda K. Marmas from personally importing any drug into the U.S. The agency based its action on evidence that Marmas engaged in a pattern of importing or offering for import misbranded drugs (i.e. in an amount, frequency, or dosage
FDA Policy/General
Speaking on a 2/3 GovFocus panel, FDA acting chief technology officer Sohail Chaudhry said automation is a key element in the agency’s digital transformation plan, with user experience at the forefront of modernization efforts. “Data and people are at the heart of FDA,” he said. A Nextgov online
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Prescription Drug User Fee Program” (OMB Control Number 0910–0297). The agency is revising the collection to include its current commitment goals as set forth in the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Establishment Registration and Device Listing for Manufacturers and Importers of Devices — 21 CFR Part 807, Subparts A Through D” (OMB Control Number 0910-0625). FDA’s regulations require medical device establishment owners and operators to electronically submit
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Clinical Pharmacology Considerations for Antibody-Drug Conjugates,” which provides recommendations for developing such products. Specifically, the document addresses the agency’s current thinking on bioanalytical methods, dose selection and adjustment, dose- and exposure-response analysis, intrinsic factors, QTc assessments,
FDA Policy/General
Federal Register notice: FDA is classifying the carbon dioxide gas-controlled tissue expander into medical device Class 2 (special controls). The action was based on an AirXpanders de novo classification request for its AeroForm Tissue Expander System. The agency identified the device as being intended for temporary subcutaneous or submuscular
FDA Policy/General
Federal Register notice: FDA is announcing a 2/15 Vaccines and Related Biological Products Advisory Committee meeting to discuss a request to amend the Emergency Use Authorization of Pfizer-BioNTech’s Covid–19 mRNA vaccine for administration to children six months through four years of age. To view the notice,
FDA Policy/General
Federal Register notice: FDA is classifying the alternate controller enabled infusion pump into medical device Class 2 (special controls). The action is based on a Tandem Diabetes Care de novo classification request for its t:slim X2 insulin pump with interoperable technology. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 1/11 notice about a draft guidance entitled “Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act.” Comments should now
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” To view the notice, click here.
FDA Policy/General
Comments Extended on Device Modeling/Simulation Guide 2/4/2022 Federal Register notice: FDA is extending the comment period for a 12/23 notice on a draft guidance entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Comments should now be submitted by 3/4. To
FDA Policy/General
Contract research organization Chiltern International has hired investment firm Jefferies to investigate a potential sale valued around $1.3 billion. Chiltern focuses on early phase and global development in oncology, dermatology, neuroscience, endocrine and metabolic, ophthalmology, gastroenterology and respiratory areas. The company has more than 4,300 sites across 47
FDA Policy/General
DEVICES Cerapedics has received FDA approval of its PMA for i-FACTOR Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. FDA has cleared a Convergent Dental 510(k) for Solea, a CO2 9.3 micron dental laser for
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format.” The document provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Population Pharmacokinetics.” The document is intended to assist sponsors in applying population pharmacokinetics during the drug development process to inform drug use. It also includes FDA’s current thinking on the data and model requirements for population PK analyses
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Assessment of Pressor Effects of Drugs.” The document is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is classifying the photoplethysmograph analysis software for over-the-counter use into medical device Class 2 (special controls). The action responds to an Apple Inc. de novo classification request for its Irregular Rhythm Notification Feature. The agency says the device has been identified as analyzing photoplethysmograph
FDA Policy/General
Federal Register notice: FDA is announcing the withdrawal of a 7/14/2011 proposed rule entitled “Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment,” The agency is taking this action because the proposed changes are duplicative of a new FDA proposed rule that
FDA Policy/General
Federal Register notice: FDA is proposing to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federal Food, Drug, and Cosmetic Act resulting from enactment of the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act. The proposed rule