Office of New Drugs: BIO Comments on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs
January 10, 2020
January 7, 2020
Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments following the FDA public meeting on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
BIO appreciates the Agency’s efforts to seek input from stakeholders on actionable policy suggestions that could be implemented in the near-term by the staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs (OND) to promote effective drug development programs without compromising regulatory standards for the assessment of safety and effectiveness. It is through discussions such as these that various stakeholders can work together to identify challenges and barriers as well as potential solutions for making drug development and review more efficient, with the shared goal of bringing safe, effective, and high-quality medicines to patients in a timely manner.
BIO has included in this letter several specific recommendations for CDER on how to promote effective drug development programs. We note that the FDA has indicated that topics such as real world evidence (RWE) and patient focused drug development (PFDD) are out of scope for the purposes of the public meeting and docket response, however, both of these topics have an integral role in improving efficiencies in drug development and regulatory decision making. Additionally, OND sits at the apex of review divisions, providing guidance on policy which may include RWE and PFDD and as a result, these topics should be kept in mind.
BIO includes comments specific to opportunities to support consistent and efficient Sponsor-FDA communication; opportunities to support consistency across OND review divisions; opportunities for additional guidance; facilitation of drug development for diseases not currently amenable to targeted therapies; the use of innovative clinical trial designs across therapeutic areas; and advancing innovative approaches.
Download Full Comments Below
BIO Comments on Promoting Effective Drug Development Programs for FDA OND
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
January 7, 2020
Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments following the FDA public meeting on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
BIO appreciates the Agency’s efforts to seek input from stakeholders on actionable policy suggestions that could be implemented in the near-term by the staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs (OND) to promote effective drug development programs without compromising regulatory standards for the assessment of safety and effectiveness. It is through discussions such as these that various stakeholders can work together to identify challenges and barriers as well as potential solutions for making drug development and review more efficient, with the shared goal of bringing safe, effective, and high-quality medicines to patients in a timely manner.
BIO has included in this letter several specific recommendations for CDER on how to promote effective drug development programs. We note that the FDA has indicated that topics such as real world evidence (RWE) and patient focused drug development (PFDD) are out of scope for the purposes of the public meeting and docket response, however, both of these topics have an integral role in improving efficiencies in drug development and regulatory decision making. Additionally, OND sits at the apex of review divisions, providing guidance on policy which may include RWE and PFDD and as a result, these topics should be kept in mind.
BIO includes comments specific to opportunities to support consistent and efficient Sponsor-FDA communication; opportunities to support consistency across OND review divisions; opportunities for additional guidance; facilitation of drug development for diseases not currently amenable to targeted therapies; the use of innovative clinical trial designs across therapeutic areas; and advancing innovative approaches.