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EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials

The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a...

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European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal products and biosimilars

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorizations from stakeholders

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Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are...

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FDA shows that it means business in stopping stem cell clinics that put patients at risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic...

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FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological ...

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Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of...

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Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials in emergency situations

On December 14, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes ...

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FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...

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EMA publishes external guidance for clinical data publication

On 22 September 2017, the European Medicines Agency ("EMA") published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical...

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FDA Simplifies and Clarifies Expanded Access Program

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program.  Under FDA’s expanded access program, physicians may...

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EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation....

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Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published.

The workshop discussed the views of ...

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