Regulatory Affairs

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

October 14 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #65 published by the Board of Directors of the National Health Surveillance Agency on August 4, 2014 which proposes a new regulation defining the procedures and requirements for conducting clinical trials involving drugs in Brazil.
October 14 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #8 published by the Brazilian Ministry of Health on August 14, 2014 which proposes a new regulation defining the guidelines and criteria for the submission, formation, monitoring and evaluation of PDP (Public-Private Productive Development Partnerships) projects.
October 14 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin.
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(BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
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