Eye on FDA
JANUARY 26, 2022
Therefore, the agency said, the indication was not adequately communicated. FDA noted that the product has a boxed warning and that there have been past advisory communications from FDA have expressed concerns. It includes 352 letters covering over 450 communications vehicles and over 1100 violations.
Express Pharma
JUNE 27, 2023
Announcing Gagandeep’s appointment, Mohammed Tawil, Regional Managing Director and Head of Human Pharma for India, Middle East, Turkey, and Africa at Boehringer Ingelheim said, “Since inception in 2003, our focus on improving patient outcomes in India remains steadfast.
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pharmaphorum
NOVEMBER 18, 2020
Scientific communications company Envision Pharma has bought Two Labs, a firm specialising in commercial solutions for the pharma and biotech sector, for an undisclosed sum. The acquisition followed an investment in Envision by specialist European fund Global Healthcare Opportunities (GHO) earlier this month.
FDA Law Blog: Biosimilars
SEPTEMBER 19, 2023
The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.
Express Pharma
MARCH 23, 2023
This is also evident from the newly published EU annexe-1, which has such an elaborate section on ‘Personnel’ as compared to its last update in 2003, with an increased reiteration of the word ‘training’ from 5 to 10 times in the current revision. Participants get multiple opportunities to correct a practice till they are perfect on the task.
Pulses
JUNE 6, 2023
This helps them to connect even outside the classroom to communicate about questions they may have and creates a stronger support system. Published December 1, 2003. Academic Benefits CL promotes critical thinking and requires active engagement in the learning process. Procedia – Social and Behavioral Sciences. 2012;31:486-490.
pharmaphorum
DECEMBER 22, 2022
There were screening recommendations back in 2003 and they have yet to be fully implemented. Korenjak philosophically entered the conversation with the comparison of the water jug on the table before him: he was thirsty, but he couldn’t reach the water, and a similar experience is what is happening in Europe, he said.
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