The FDA Law Blog
JULY 10, 2023
FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.
European Pharmaceutical Review
JANUARY 25, 2024
7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Article 63 EMA (29 January 2020). Even in countries with high smartphone usage such as Denmark, up to 25 percent of the population do not possess a smartphone.
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DiversifyRx
NOVEMBER 3, 2022
He created DB Diagnostics in 2020. All our cleared products have a package insert listed under the product, and all the information you need for the form is found there. In addition to selling tests, Kavel has solutions for online appointments, websites, and test results communication to patients or government entities.
pharmaphorum
AUGUST 17, 2020
“A lot of printed materials have been migrated to digital so that patients can opt-in to receive digital communications or HCPs can receive digital product or disease state information in the form of rep-triggered emails and microsites. Joanna Carlish. The idea is about really tapping into where the customer is in their journey.
pharmaphorum
APRIL 11, 2022
The European Commission’s Pharmaceutical Strategy for Europe , adopted in November 2020, outlines a series of concrete actions to ensure accessibility, availability, and affordability of medicines. Data will always be central to everything we do, as it has the power to communicate the potential of a new treatment to change a person’s life.
pharmaphorum
FEBRUARY 2, 2022
As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. The ability to communicate with participants via video call may make the trial more inclusive geographically, but can also exclude people from a technology standpoint, for instance.
ISPE
OCTOBER 26, 2022
Reintroducing the liaison role of International Board members with individual Chapters and Affiliates has given us direct lines of communication to the mutual benefit of the International Board and the local groups. What else did I do as Chair this year, in addition to running the Board and its meetings plus sitting on numerous committees?
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