2014 Communication Labelling 
RX Note
DECEMBER 25, 2024
Labelling Requirements A ll dispensed medicine should be labelled according to the requirement stated by the law. NOTE: It is advisable for labels to be printed. Consequently, a patient-centred label strategy is introduced to promote appropriate medication use and adherence. Suggestions include Use larger font sizes (e.g.
FDA Law Blog: Biosimilars
OCTOBER 24, 2023
By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).
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Eye on FDA
AUGUST 2, 2022
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
Eye on FDA
JUNE 14, 2023
The numbers plummet in 2014 until the record low last year of only 4 letters. The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). The last letter issued came just over a year ago in June, 2022.
ALiEM - Pharm Pearls
MARCH 7, 2024
Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Cysts will have a more spherical shape and will not “communicate” with one another [5]. 2014 Nov;22(4):213-22. Epub 2014 Nov 10. Ultrasound. cited 2023 July 4].
Eye on FDA
JULY 7, 2020
In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). One of them was about the appropriate use of links.
RX Note
MARCH 23, 2023
Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.
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