FDA Policy/General
Info Collection Revision on Drug Reporting 12/10/2021 Federal Register notice: FDA has submitted to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). The collection supports statutory provisions regarding the monitoring of
FDA Policy/General
DEVICES FDA has approved a FujiFilm Medical Systems PMA for the Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system. “With the DBT software option, the x-ray tube moves through an arc around the breast, acquiring a series of low-dose image
FDA Policy/General
Momenta Pharmaceuticals and Mylan have entered into a collaboration agreement to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including a version of Bristol-Myers Squibb’s Orencia (abatacept), indicated for treating rheumatoid arthritis. Under the agreement, Mylan will make an upfront $45 million cash payment to
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products. Comments can be submitted until 1/24/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Labeling Requirements for Prescription Drugs” (OMB Control Number 0910-0572). The collection supports FDA regulations governing the labeling of prescription drugs, and sets forth both general and specific content and format requirements. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. The guidance outlines the types of changes to be documented in annual reports: changes that FDA generally considers to have a minimal potential to have
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Fresenius Kabi NDA for Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection). The company notified the agency that the product is no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. Comments on the document are being accepted until 3/9/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing modifications to its list of standards FDA recognizes for use in premarket reviews: “Modifications to the List of Recognized Standards, Recognition List Number: 056.” The list is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for
FDA Policy/General
Appearing in a Milken Institute video interview with former FDA commissioner Margaret Hamburg, current acting commissioner Janet Woodcock said she hopes incoming commissioner Robert Califf will continue modernizing information technology in the agency as well as continuing to work to lower sodium in food and shepherding several user fee programs
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations. The clinical recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations. The document provides FDA’s recommendations on the chemistry, manufacturing, and controls information needed to support an IND for
FDA Policy/General
Federal Register notice: FDA is publishing an order on its final determination involving a petition requesting exemption from premarket notification (510(k)) requirements for the generic device type: powered patient transport (product code ILK). FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety
FDA Policy/General
Former FDA commissioner Stephen Hahn has been named CEO of Flagship Pioneering’s new Harbinger Health startup. Flagship describes Harbinger as a bio-platform company pioneering the detection of early cancer with a simple blood test that combines artificial intelligence (AI) and machine learning advances with its recent discoveries about
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. To view the notice, click here.
FDA Policy/General
Regulatory Review Period Determined for Dojolvi 12/2/2021 Federal Register news: FDA has determined for patent extension purposes the regulatory review period for Ultragenyx’s Dojolvi (triheptanoin), indicated as a source of calories and fatty acids for treating pediatric and adult patients with molecularly confirmed long-chain fatty acid
FDA Policy/General
DEVICES FDA has cleared a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. The systems are available in two designs, Ozark Guide and Ozark View, both featuring an
FDA Policy/General
Astellas and Anokion will create Kanyos Bio to collaborate on developing new treatments for Type 1 diabetes and celiac disease. DalCor Pharmaceuticals and the Montreal Heart Institute will conduct an international Phase 3 clinical trial seeking to validate the clinical efficacy of dalcetrapib, that according to an MHI published could
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is classifying the intraoperative orthopedic strain sensor into Class 2 (special controls). The decision is based on an Intellirod Spine de novo classification request for its Loadpro Intraoperative Rod Strain Sensor. The agency has identified it as an adjunct tool intended to measure strain on an
FDA Policy/General
Federal Register notice: FDA is classifying the trunk and limb electrical stimulator to treat headache into Class 2 (special controls). The decision is based on a Theranica Bioelectronics de novo classification request for its Nerivio Migra device. The agency has identified it as a device intended to treat headache through
FDA Policy/General
It appears FDA acting commissioner Janet Woodcock will continue to play a senior role at the agency if FDA commissioner nominee Robert Califf is confirmed by the Senate. Califf reportedly has asked Woodcock to stay on in the Office of the Commissioner, but it is not clear whether he will