FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

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European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. 2013 Oct; 48(10): 943–953. Thompson, LA.

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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. per cent of global patents to almost 2 per cent.

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pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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Drug Development Documentation 98

European Pharmaceutical Review

FEBRUARY 1, 2024

In this Q&A, he explores the trends and challenges within the cardiovascular treatment space, as well as clinical development of the company’s lead candidate obicetrapib, a cholesterol ester transfer protein (CETP) inhibitor for lowering low-density lipoprotein-cholesterol (LDL-C) and ultimately reducing cardiovascular risk.

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Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97

European Pharmaceutical Review

JANUARY 16, 2023

“Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He warned, “Implementation of a CCS will require more than writing documents.”.

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Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Journal of the American College of Cardiology , 71(18), 1960–1969.

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Communication Clinical Pharmacology Documentation Drug Development 52