Compassionate Use

Global Policy on Expanded Access / Compassionate Use - Incyte.com

This Policy applies to the provision of Incyte investigational products to patients through. Expanded Access / Compassionate Use programs. If you have any ...

The Global Guide to Compassionate Use Programs

Compassionate Use and Expanded Access programs, a comprehensive guide to complex country regulations, formal guidance documents, submission requirements, ...

Early Access Policy - Shionogi Inc.

... compassionate use, managed access, special access, expanded access, named patient, and temporary authorizations for use programs), Shionogi may be able to ...

Resources and Information for Patients - Regeneron Pharmaceuticals

Our Compassionate Use Policy gives certain patients who have serious or life-threatening conditions access to a potentially beneficial medicine when no ...

Medicinal Product Managed Access Programs - Servier

... Access Programs” (MAPs). MAP covers different terms including “Compassionate Use”, “Early Access Authorization”, “Expanded Access”, “Named Patient Program ...

Early Access & Compassionate Use Program - Apellis Medical Hub

Early Access & Compassionate Use Program. We are committed to developing innovative therapies for patients with serious diseases. Clinical trials are a critical ...

Managed access programs - Novartis

The Novartis “Managed Access” terminology covers all locally defined pre-approval access mechanisms and programs such as “Compassionate Use”, “Expanded ...

Expanded Access and Compassionate Use - HPO

Expanded access. (or compassionate use) provides access to investigational products (drug, biologic, or medical device) outside a clinical trial.

Compassionate Use Program - Norwegian Medical Products Agency

The Norwegian Medical Products Agency evaluates and approves applications for the Compassionate Use Program (CUP).

Compassionate use/Named Patient Use - BASG

Compassionate use facilitates the provision of unauthorised medcinal products to patients for whom no adequate treatment modalities exist.

Emergency Use, Compassionate Use, or Expanded Access

Compassionate Use or Expanded Access. Compassionate uses (for devices) and expanded access uses (for drugs or biologics) are scenarios in which ...

Compassionate Use | Voisin Consulting Life Sciences

Compassionate Use ... The use of an unauthorised medicine outside a clinical study in individual patients under strictly controlled conditions. This helps to make ...

Expanded Access | NIH - Clinical Info HIV.gov

Expanded Access pronounce term. Audio. Your browser does not support the audio element. 830.mp3. Synonym(s). Compassionate Use. Legal use of an investigational ...

Expanded Access Policy - Ionis Pharmaceuticals

Expanded access, also referred to as compassionate use, is one potential pathway for people with life-threatening diseases to gain early access to an ...

Compassionate use trials and equitable access to variant-specific ...

Compassionate use trials and equitable access to variant-specific treatment for cystic fibrosis. Katherine Odem-Davis.

Expanded Access Program - BeiGene

In very specific circumstances, these patients may be able to receive investigational medicines outside a controlled clinical trial through compassionate use ...

Compassionate use of unauthorized drugs: Legal regulations and ...

Compassionate use by its nature creates a conflict between the needs of some patients and those of the whole society. On the one hand, for patients with serious ...

Compassionate use, clinical - GARDP Revive

Compassionate use, clinical. Definition: Synonym: expanded access. Providing ... Regulatory authorities provide guidance outlining the circumstances when ...

Medicines | Expanded Access - Vertex Pharmaceuticals

These situations are often referred to in various ways, including managed access, expanded access, early access, preapproval access, compassionate use and ...

Ethics review in compassionate use | BMC Medicine | Full Text

The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical ...