HIT Consultant
JANUARY 8, 2024
Imbed Biosciences has developed the world’s first and only fully-synthetic and antimicrobial wound matrix, which is FDA-cleared. This FDA-cleared biocompatible polymer matrix creates a healing environment conducive to tissue growth while suppressing harmful microbes and biofilms.
HealthIT Answers
SEPTEMBER 27, 2023
Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency's technological advancement and the alignment with its broader public health mission. By Vid Desai & Jessica N. Berrellez - The U.S.
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Healthcare Law Today
FEBRUARY 1, 2022
Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.
Hall Render
NOVEMBER 30, 2023
On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).
Hall Render
JUNE 5, 2024
In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.
HIT Consultant
MARCH 13, 2023
Seagen Background Seagen is a pioneer in ADC technology, with four of the twelve total FDA-approved and marketed ADCs using its technology industry-wide. Seagen’s medicines, late-stage development programs and pioneering expertise in Antibody-Drug Conjugates (ADCs) strongly complement Pfizer’s Oncology portfolio.
Dot Compliance
FEBRUARY 1, 2022
Food and Drug Administration (FDA) recently issued pharma industry guidance documents that will impact how companies collect, manage and submit quality data to the agency. Data in the regulatory spotlight. Here are two points worth noting as we head into the new year. Data is the name of the game in 2022 and beyond. References. References.
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