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FDA
Patient Access to Medical Innovation Act Introduced
U.S. Senator Al Franken (D-Minn.) introduced the bipartisan Patient Access to Medical Innovation Act (S. 1865) to get innovative…
FDA Innovation Pathway and Extension of Comment Period on Medical Device…
Over the past year or so, there has been a tremendous amount of attention on the Food and Drug Administration (FDA)…
FDA’s Blue Print for Innovation
The Food and Drug Administration (FDA) is one of the most important federal agencies in America. The agency regulates…
FDA REMS: Blue Print for Prescriber Continuing Education Program for…
The Food and Drug Administration (FDA) released a “Blueprint for Prescriber Continuing Education Program” regarding the use of…
Patient Groups Encourage Congress to Remove Burdensome FDA Rules
Patient organizations are encouraging congress to drop burdensome conflict of interest quotas on FDA advisory panels which are…
FDA “Consumer Groups” Sidestep PDUFA Meetings
According to a letter obtained by FDA Week, “a coalition of patient, consumer and public health advocates is bypassing the Food…
The Cultivating Scientific Expertise to Foster Innovation for Patients Act…
As we noted last week, a group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael…
Medical Device Regulatory Improvement Act Introduced: Senators Call for…
A group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC),and Michael Bennet (D-CO)…
FDA Guidance on Informed Consent
The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) released last month a new guidance,…
FDA Biosimilars Guidance Coming Soon
Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide…