FDA Law Blog: Biosimilars
JUNE 11, 2023
However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. Still, however, it appears FDA has had enough of these 16%.
Eye on FDA
AUGUST 2, 2022
By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year.
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European Pharmaceutical Review
JULY 20, 2023
He advises clients through all stages of the product lifecycle, including product development, trademark clearance, labelling, advertising and promotion, product launch, distribution, licensing and compliance. Lara Sophie Hucklenbroich supports counselling life sciences clients from the pharmaceutical, medical devices, and food industries.
RX Note
JULY 29, 2023
Comparison of oral versus normal and high-dose rectal acetaminophen in the treatment of febrile children, 2002 Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial, 2005 Key Messages Paediatric doses are generally based on body-weight (in kg) specific age ranges.
pharmaphorum
FEBRUARY 26, 2021
Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. Weldon became the Chairman and CEO of J&J in 2002. Johnson’s Baby Powder also went on sale during this year and was extremely successful. billion the following February.
PharmaState Academy
DECEMBER 12, 2023
. ———————— Healthcare Professional Facing Advertising NDA discussed the legal regulations – UCPMP and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Code) and ethical considerations surrounding the promotion of products in the healthcare industry.
European Pharmaceutical Review
SEPTEMBER 22, 2023
Prior to joining Novimmune in 2002, she was Head of Immunology and Preclinical Pharmacology at the Serono Pharmaceutical Research Institute, a Senior Scientist and then Head of Immunology at the Glaxo Wellcome Research Institute in Geneva, and a Scientific Member of the Basel Institute for Immunology. Landry I, Kanekiyo M, Aluri J, et al.
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