Biosimilars, Packaging and Workshop

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Biosimilars

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Sustainability is more than a commitment, it’s a path to operational efficiency and long-term value creation

Express Pharma

AUGUST 13, 2024

billion green loan to fund its purchase of Viatris’ biosimilars business. General Secretary at IDMA (Indian Drug Manufacturers Association), I am proud to say that IDMA has played a crucial role in this transition, organising workshops across the country in collaboration with the Central Drugs Standard Control Organisation (CDSCO).

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Packaging Biosimilars Pharmaceutical Companies

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.

Documentation

Documentation Packaging Clinical Pharmacology Drug Development

Pharmacist Digest

Sustainability is more than a commitment, it’s a path to operational efficiency and long-term value creation

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

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