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.
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).
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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.
ISPE
NOVEMBER 23, 2022
Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.
The FDA Law Blog
JUNE 7, 2023
Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Second, Merck argues that the parody of a negotiation and a fair price compels speech in violation of the First Amendment.
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.
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