BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials.
BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the pilot program to promote public learning about…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products.
The Prescription Drug User Fee Act (PDUFA) meeting structure fosters robust…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Compounded drugs can serve an important role for patients who have clinical needs…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry.
This guidance is an important step towards providing information to patients and providers about the…
BIO submitted comments to the Food and Drug Administration’s (FDA) on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation, following the Public Workshop on May 9, 2018.
While advances in genomics and precision medicine have significantly improved the…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.
The draft guidance is a positive step toward articulating a streamlined, science-based approach for…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.
The draft guidance is an important step towards ensuring stakeholders understand FDA’s expectations regarding the inclusion…
Letters, Testimony & Comments | September 11, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.
In the comments, BIO applauds the FDA’s initiative to advance the use of patient-experience data (PED) to inform drug development…
Letters, Testimony & Comments | September 21, 2018
BIO submitted comments for the Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace, which took place on September 4, 2018. BIO remarked on the need to foster a robust, competitive marketplace for biological products to…
Letters, Testimony & Comments | September 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.
It’s important to…