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Jul 2, 2015

 
FDA Releases Guidance for Acceptance of clinical Data from trials outside the USA
New Guidance issued by FDA for sponsors of medical devices who want to use their clinical data from trials outside the US for an FDA submission

This is a new draft policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States.

Read the pdf



Widler & Schiemann AG support WHO on GCP Training
Two successful workshops conducted in the Philippines and Nigeria

WHO has again chosen Widler & Schiemann AG to support their effort in GCP education around the world. Beat Widler was conducting two GCP workshops, one in Manila, Philippines and another in Abuja, Nigeria.





FDA’s page on Expanded Access Programs
FDA’s current policies on compassionate use can be found on this homepage

Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices.

Wherever possible, use of an investigational medical product by a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when patient enrollment in a clinical trial is not possible (e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials), patients may be able to receive the product, when appropriate, through expanded access.

Read more online



FDA on early trials in Cellular and Gene Therapy Products
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

This guidance is to assist sponsors and investigators in designing early-phase clinical trials for cellular therapy (CT) and gene therapy (GT) products. CT and GT products will be referred to collectively as CGT products. This guidance provides OCTGT’s current recommendations regarding clinical trials in which the primary objectives are the initial assessments of safety, tolerability, or feasibility of administration of investigational products. Such trials include most Phase 1 trials, including the initial introduction of an investigational new drug into humans, and some Phase 2 trials of CGT products.

The scope of this guidance is limited to products for which OCTGT has regulatory authority. CGT products within the scope of this guidance meet the definition of “biological product” in section 351(i) of the Public Health Service (PHS) Act (42 U.S.C. 262(i)) and include CT and GT products that are used as therapeutic vaccines.

Read the pdf

 

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