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FDA
FDA: Initiative to Vet Advertising of Newly Approved Products, the Launches…
Recently, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP), which was formerly the Division of…
FDA Seeks Input on Device Classification System
Recently, the Food and Drug Administration (FDA) opened up a public comment period, extending to mid-January, to get perspective…
FDA REMS to Promote Closer Ties to Healthcare Professionals
A recent article from the Food Drug Law Institute (FDLI) Update Magazine, discussed a recent session entitled “The Impact of…
Senator Kay Hagan Encourages FDA to Consider Faster Approval Pathway for…
A recent article from Bloomberg noted that, “Congressional talks to renew the fees drugmakers pay to fund Food and Drug…
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…