Express Pharma

MARCH 16, 2025

First, advanced research and development (R&D) and biologics will be critical. To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs.

Biosimilars 98

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

Express Pharma

OCTOBER 19, 2024

Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D. References [link] [link] 281%29.pdf

Drug Development 111

Drug Development Documentation 111

Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. For drugs, the relevant CDER/CBER Division may or may not provide feedback; sponsors with specific questions may include them as a topic for discussion in meetings with FDA.

Drug Development 59

Drug Development Communication Documentation Labelling 59

Fuld & Company Blog

MARCH 12, 2025

The ultimate guide to 2025 healthcare and life sciences conferences Stay ahead of the latest developments and networking opportunities in the health and life sciences sector with Fulds 2025 Health & Life Sciences Conference Directory. Whats inside?

Documentation 52

Documentation Drug Development 52

FDA Law Blog: Biosimilars

JANUARY 30, 2025

To this end, the December 2024 draft guidance and a companion guidance published January 7, 2025, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (the January 2025 draft guidance ) describe FDAs latest thinking on what it means to conduct a confirmatory trial with due diligence.

Drug Development 105

Drug Development Documentation 105

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

Documentation 88

Documentation Drug Development 88