Express Pharma
MARCH 19, 2025
hour workshop provided participants with direction, supplementary documentation, and hands-on learning, ensuring they were well-equipped to meet compliance requirements. Close to 200 participants attended the online workshop. He provided detailed responses on compliance challenges & documentation requirements.
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
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Integrated Primary Care
APRIL 14, 2021
As clinicians learn to write notes that patients can read, they tend to become more patient-centered in their clinical work as well as in their documentation. It is much easier to make a patient a partner in their care when they are a partner in the informational record of their care.
Pharmaceutical Technology
JULY 18, 2025
Nonetheless, one of the significant outcomes of the Hub’s work has been setting up the framework for the Rare disease Innovation Science and Exploration (RISE) workshop series, which is designed to take a deep dive into an issue relevant to the rare disease space.
FDA Law Blog: Biosimilars
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
European Pharmaceutical Review
MAY 18, 2023
A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.
Express Pharma
OCTOBER 4, 2023
These workshops are set to continue over the next few months. However, annual audits would add to the documentation and administrative cost of doing business, especially painful for the MSME sector. This is clearly linked to instances of Made in India cough syrups found to contain high levels of the toxic diethylene glycol (DEG).
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