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.
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.
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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.
Healthcare IT Today
DECEMBER 30, 2024
This shift, driven by the FDA’s Diversity Action Plans, will accelerate trial enrollment, improve representation, and ultimately enhance patient safety by ensuring more diverse data in research. are expected to reach $6 trillion by 2027, representing roughly 18% of the GDP.
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.
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