Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access to U.S. persons who rely on IP protection. As part of the 2020 Special 301 Review process conducted by USTR, Justin Pine prepared BIO’s formal submission and presented oral testimony to USTR and the interagency Special 301 subcommittee highlighting the IP issues facing our members in key markets around the world.
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on…
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how…
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Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access to U.S. persons who rely on IP protection. As part of the 2020 Special 301 Review process conducted by USTR, Justin Pine prepared BIO’s formal submission and presented oral testimony to USTR and the interagency Special 301 subcommittee highlighting the IP issues facing our members in key markets around the world.