Washington Legal Foundation’s Post

In a recent practice note for LexisNexis Practical Guidance, attorneys Kelly Del Dotto and Brian Coggio examine the PTO's 2022 notice on the duty of disclosure. They offer crucial insights for life sciences attorneys navigating the complex interplay between patent law and regulatory submissions, emphasizing the importance of consistent communications across government agencies and providing strategies for ensuring compliance. Read more: https://hubs.li/Q02Q0XQx0 #FishRichardson

On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When finalized, the Draft Guidance will update a previously issued FDA guidance (the “2019 Interchangeability Guidance”) to remove a recommendation that a biosimilar applicant conduct switching studies to demonstrate the interchangeability of its biosimilar product with the reference product. Citing the two agencies’ “long history of collaborative efforts to support competition and non-deceptive advertising in pharmaceutical markets,” the FTC lauds the Draft Guidance, saying it “would likely have a positive impact on the number of biosimilars designated as interchangeable and on the uptake of biosimilar products by reducing barriers to entry and increasing competition among biologic products.”

On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When finalized, the Draft Guidance will update a previously issued FDA guidance (the “2019 Interchangeability Guidance”) to remove a recommendation that a biosimilar applicant conduct switching studies to demonstrate the interchangeability of its biosimilar product with the reference product. Citing the two agencies’ “long history of collaborative efforts to support competition and non-deceptive advertising in pharmaceutical markets,” the FTC lauds the Draft Guidance, saying it “would likely have a positive impact on the number of biosimilars designated as interchangeable and on the uptake of biosimilar products by reducing barriers to entry and increasing competition among biologic products.”

On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When finalized, the Draft Guidance will update a previously issued FDA guidance (the “2019 Interchangeability Guidance”) to remove a recommendation that a biosimilar applicant conduct switching studies to demonstrate the interchangeability of its biosimilar product with the reference product. Citing the two agencies’ “long history of collaborative efforts to support competition and non-deceptive advertising in pharmaceutical markets,” the FTC lauds the Draft Guidance, saying it “would likely have a positive impact on the number of biosimilars designated as interchangeable and on the uptake of biosimilar products by reducing barriers to entry and increasing competition among biologic products.”

On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When finalized, the Draft Guidance will update a previously issued FDA guidance (the “2019 Interchangeability Guidance”) to remove a recommendation that a biosimilar applicant conduct switching studies to demonstrate the interchangeability of its biosimilar product with the reference product. Citing the two agencies’ “long history of collaborative efforts to support competition and non-deceptive advertising in pharmaceutical markets,” the FTC lauds the Draft Guidance, saying it “would likely have a positive impact on the number of biosimilars designated as interchangeable and on the uptake of biosimilar products by reducing barriers to entry and increasing competition among biologic products.”

On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When finalized, the Draft Guidance will update a previously issued FDA guidance (the “2019 Interchangeability Guidance”) to remove a recommendation that a biosimilar applicant conduct switching studies to demonstrate the interchangeability of its biosimilar product with the reference product. Citing the two agencies’ “long history of collaborative efforts to support competition and non-deceptive advertising in pharmaceutical markets,” the FTC lauds the Draft Guidance, saying it “would likely have a positive impact on the number of biosimilars designated as interchangeable and on the uptake of biosimilar products by reducing barriers to entry and increasing competition among biologic products.”

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.