Blog Post
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...
Blog Post
The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorizations from stakeholders
Blog Post
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...
Blog Post
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...
Blog Post
In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological ...
Blog Post
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...
Blog Post
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 ...
Blog Post
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in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...
Blog Post
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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Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may...
Blog Post
In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation....
Blog Post
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 ...
