COALITION SUBMITS COMMENTS ON DRAFT GUIDANCE

The Coalition for PET Drug Approval submitted comments to the FDA on the draft guidance entitled “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”.

The draft guidance document is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs). The draft guidance summarizes the IND process for PET drugs, makes recommendations for how to submit an IND, provides advice on expanded access options for investigational PET drugs, and describes the process for requesting permission to charge for an investigational PET drug.

The Coalition comments focus on the limits to the number of patients and the amount of time that the expanded access IND may be held by the physician investigators. To view the comment letter, CLICK HERE

Advertisements
This entry was posted in PET Drugs. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s