Regulatory Affairs

Providers and policy makers must collectively address the profound effect the red-tape hassle can have on the practice of oncology.

July 28 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.
February 3 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
November 20 2013
BIO welcomes the opportunity to provide the views of its members on facilitating access to genetic resources and traditional knowledge and the sharing of benefits from their use...
November 18 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products.”  
November 5 2013
BIO thanks FDA for releasing this Draft Guidance specifying the Data Universal Numbering System (DUNS) number as FDA’s preferred Unique Facility Identifier (UFI) system in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA) sections 701 and 702.  BIO supports FDA’s effort to have a single facility identification system in order to facilitate FDA’s activities that follow-on to registration which help secure patient and consumer safety, and we have several recommendations and requests for clarification on the proposal put forth in the Draft Guidance.
August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
May 7 2014
Pediatric research is essential to study the effects of new therapeutics in children
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines.
February 26 2014
Transparent communication important for Patients and Physicians
October 22 2013
Pending Legislation will Protect Indiana Citizens Utilizing Biologic Medications to Manage Chronic Diseases and other Unmet Medical Needs