Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
Biosimilars 2018 - A Year in Review
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more
Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability....more
On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more
On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products –...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any recommendation that...more
On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. ...more
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA...more
Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. FDA justified its reversal on including the...more
In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and...more
The U.S. Food and Drug Administration (FDA) is considering comments to their risk-focused draft guidance, “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers-Patient Labeling Recommendations.” Although LASIK is one of the...more
In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised...more
The Food and Drug Administration (FDA) updated a final guidance and a companion draft guidance (the “first draft guidance”) providing answers to questions related to the agency’s regulation of biosimilar products and its...more
As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory,...more
On November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the submission of biologics license applications (BLAs) and labeling for...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...more
The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine....more
The U.S. Food and Drug Administration has permitted limited use of the antimalarial drugs hydroxychloroquine and chloroquine in the treatment of COVID-19 since issuing an Emergency Use Authorization for such drugs on March...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice. ...more