Elizabeth Kim

Loeb & Loeb LLP

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What’s In a Name? The Value of Pharmaceutical & Biologic Branding

September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch- Waxman strove to offer consumers the benefits of “rapid...more

9/15/2014 - Biologics FDA FDCA Hatch-Waxman Pharmaceutical Prescription Drugs

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

7/17/2014 - Advertising Draft Guidance FDA Health Care Providers Medical Devices Pharmaceutical Pharmaceutical Manufacturers Popular Prescription Drugs Social Networks

FDA Releases Long-Awaited Guidances on Character Limitations and Misinformation on Internet/Social Media

In two separate guidances, the Food and Drug Administration (FDA) advises prescription drug and device manufacturers on its "current thinking" on advertising through space-constrained social media (e.g., Twitter) and on the...more

6/24/2014 - Advertising FDA Internet Marketing Prescription Drugs Social Media Twitter

Senate Committee Questions FDA's Use of Draft Guidances

In a letter to the Food and Drug Administration, a group of U.S. senators from the Committee on Health, Education, Labor & Pensions expressed "significant" concern about the agency's apparent reliance on a process of issuing...more

5/20/2014 - FDA Final Guidance Guidance Update Legislative Committees Public Comment Public Policy

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

3/11/2014 - FDA FDAMA Medical Devices Pharmaceutical

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