Elizabeth Kim

Elizabeth Kim

Loeb & Loeb LLP

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FDA Regulatory and Compliance Monthly Recap – May 2016

FDA draft guidance provides recommendations on use of electronic health record data in clinical trials - The draft guidance provides recommendations on deciding whether and how to use EHRs as a source of data in clinical...more

6/2/2016 - 3D Printing Clinical Laboratory Testing Data Integrity Draft Guidance EHR FDA Life Sciences Manufacturers Medical Devices Pharmaceutical Industry Recordkeeping Requirements Surveillance

FDA Regulatory and Compliance Monthly Recap — April 2016

FDA finalizes guidance on drug design in attempt to reduce medication errors - The finalized guidance revises draft guidance published in 2012 to address public comments calling for clarifications and formatting changes,...more

5/3/2016 - Biosimilars Draft Guidance Drug Design FDA Food Labeling Prescription Drugs Proprietary Information Warning Letters

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

4/7/2016 - Clinical Trials FDA FDA Warning Letters FDASIA Medical Devices NIH

FDA Regulatory and Compliance Monthly Recap — February 2016

FDA publishes guidance on human factors review for devices, combination products - The FDA published two draft guidance documents and one final guidance document to address the incorporation of human factors studies in...more

3/1/2016 - Data Collection Draft Guidance FDA FDA Commissioner Medical Devices Political Appointments Premarket Approval Applications Safety Precautions

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 Industry 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FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar.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 Industry 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 Industry

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