Bill of Health
SEPTEMBER 13, 2023
2024) in the Berkeley-Harvard Exchange Program. His current research focuses on tensions between the patent incentive system, the FDA approval process, and insurance carriers. She has previously published research papers on transplant immunology, birth tourism in the Canadian health care system, and global COVID-19 seroprevalence.
HIT Consultant
FEBRUARY 8, 2022
. – Lucira’s COVID-19 testing platform produces lab-quality molecular testing in a single-use, consumer-friendly, palm-size test kit powered by two AA batteries. A fourth tranche of $15M may be made available prior to March 15, 2024, as determined by Hercules and SVB.
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SQA
FEBRUARY 26, 2024
The Commission will take more steps this and next year, including legislative measures, financial support, and creating an EU Drugs Agency by summer 2024. PCPC will continue to offer feedback to the FDA on the agency’s implementation of MoCRA and is encouraging member companies to prepare for registration and listing.
C&M Health Law
JANUARY 25, 2023
Notably, the Act neither fulfilled the Biden Administration’s request for additional COVID-19 response funding nor included the Verifying Accurate Leading-edge In Vitro Clinical Test (IVCT) Development (VALID) Act, which proposed updating the current diagnostic testing regulatory framework.
Health Law Advisor
MAY 20, 2022
Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.
Healthcare IT News - Telehealth
MAY 30, 2023
The COVID-19 public health emergency came to an end on May 11. This also happens to coincide with the World Health Organization declaring an end to the COVID-19 global health emergency. This also happens to coincide with the World Health Organization declaring an end to the COVID-19 global health emergency.
HIPAA Journal
DECEMBER 22, 2022
In September, the Food and Drug Administration (FDA) appropriations bill was passed to ensure the FDA continued to be funded, but in order for the bill to be passed, the FDA was forced to drop its proposed medical device cybersecurity requirements, many of which were taken from The Protecting and Transforming Cyber Health Care (PATCH) Act.
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