Big Molecule Watch
FEBRUARY 20, 2024
DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” The final rule goes into effect on March 13, 2024.
Express Pharma
DECEMBER 11, 2023
So, in this article, we delve into this dynamic market to explore the driving factors behind its exponential growth and the trends shaping the market landscape while evaluating the pain points that need to be addressed for sustained growth. trillion by 2024, with 30 per cent representing the cold chain portfolio. billion in 2022.
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Safe Biologics
DECEMBER 6, 2023
REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Read the full BioSpace article here.
Proxsys Rx
APRIL 19, 2024
And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team.
Proxsys Rx
JANUARY 12, 2024
And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team.
Fuld & Company Blog
MAY 15, 2023
Technology was used to handle costly administration issues. The Resulting Package By 2020, it was clear that One Medical was hitting a positive note with the market, and so it went public. If in-person, when patients arrived at the clinic, they would only see a receptionist and a doctor. Prime and, of course, One Medical members.
European Pharmaceutical Review
FEBRUARY 7, 2023
Some of the current and anticipated proposals will not be adopted in 2023, or even before the end of tenure of the current European Commission in late 2024. of the MDR and Article 110.4 In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR.
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