Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs

Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs

FDA is amending its investigational new drug application (IND) regulation with two final rules:

Expanded Access to Investigational Drugs for Treatment Use (PDF - 603KB)
http://www.federalregister.gov/OFRUpload/OFRData/2009-19005_PI.pdf

Charging for Investigational Drugs (PDF - 394KB)
http://www.federalregister.gov/OFRUpload/OFRData/2009-19004_PI.pdfFDA News Release (8/12/2009)

The final rule, “Expanded Access to Investigational Drugs for Treatment Use,” amends regulations on expanded access to investigational new drugs for treating patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use will be available to:

individual patients, including in emergencies
intermediate-size patient populations
larger populations under a treatment protocol or treatment investigational new drug application (IND)
It is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. The rule goes into effect 60 days from date of publication in the Federal Register.

The final rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” amends the IND regulation on charging patients for investigational drugs. The rule revises the charging regulation to clarify the circumstances under which charging for an investigational drug in a clinical trial is appropriate, set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in FDA's final rule on expanded access for treatment use of investigational drugs, and
clarify what costs can be recovered.
The rule permits charging for a broader range of investigational and expanded access uses than is explicitly permitted in current regulations. The rule goes into effect 60 days after its publication in the Federal Register.

abrir aquí para acceder al documento FDA completo y asimismo poder bajar los archivos PDF citados (doble vía, se puede hacer desde los vínculos previamente habilitados, o bien desde aquí):
Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs