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FDA Regulatory – Biocom California Advocacy

Regulatory Policy

Biocom is dedicated to improving the drug and device review and approval process, communication between industry and FDA, and transparency and accountability within the agency. Biocom monitors and engages on important regulatory matters on behalf of the California life science community, including the regulatory pathway for the approval of biosimilar products established by the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the regulation of compounded products, mobile apps, laboratory-developed tests (LDTs), Next-Generation Sequencing (NGS) tests, and the new drug tracing and UDI (Unique Device Identification) systems, among others.

21st Century Cures

Biocom applauded the passage of the 21st Century Cures Act in Congress in December 2016.The measure makes much needed changes to our regulatory environment to improve our innovation ecosystem, from discovery to development to delivery, and includes provisions to enhance efficiency, hiring, and training at the NIH and FDA, improve electronic health records (EHRs), a priority review pathway for breakthrough medical devices, a limited population approval pathway for antibiotics, an expansion of the priority review voucher program for rare pediatric diseases, clear standards for biomarker acceptance and qualification, as well as provisions to advance the use of modern trial designs and real-world evidence, among others.

User Fees Reauthorization

In August 2017, President Trump signed the FDA Reauthorization Act (FDARA) of 2017 into law. The legislation reauthorizes the prescription drug, medical device, generic drug, and biosimilar user fee agreements. The agreements are negotiated every five years by the FDA and industry and amended and approved by Congress. Industry agrees to pay higher fees to the FDA to supplement the agency’s review and approval activities in exchange for FDA’s commitment to reviewing products faster and meeting performance goals. FDA will build upon provisions included in the 21st Century Cures Act, including incorporating patient perspectives into the drug development process, facilitating the use of innovative clinical trial designs and real-world evidence, and improving communication, accountability and predictability.

Biocom Policy Statements

  • Biocom Comment Letter – Expedited Programs for Regenerative Medicine Therapies for Serious Conditions – Download
  • Biocom Comment Letter – Evaluation of Devices Used with Regenerative Medicine Advanced Therapies – Download
  • Biocom 21st Century Cures Press Release – Download
  • Biocom User Fees Press Release (House) – Download
  • Biocom User Fees Press Release (Senate) – Download
  • Biocom Compounded Drugs Comments to FDA – Download