European Pharmaceutical Review
NOVEMBER 2, 2022
The report suggested health research is a key area for R&D investment to align activity with broader social goals, communicate a clear strategic direction and improve R&D funding by crowding novel investment. . The government would need to invest an extra £1 billion in R&D by 2027. billion over a decade.
The FDA Law Blog
JUNE 8, 2023
The pandemic had changed the way people live, work and communicate. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. Such changes are not limited to personal circumstances. The pandemic also deeply impacted how industry and the government conduct their operations.
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The FDA Law Blog
SEPTEMBER 16, 2024
This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.
The FDA Law Blog
NOVEMBER 17, 2022
patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).
The FDA Law Blog
NOVEMBER 21, 2022
patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).
Viseven
JUNE 12, 2023
from 2022 to 2027. Though South Korea is the third largest biopharma innovation hub, Suyoung admits that local pharma companies have low HCP engagement rates because marketers still use traditional methods of communication such as email, phone calls, and face-to-face visits. And it makes sense.
The FDA Law Blog
JUNE 14, 2023
In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).
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