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FDA finalizes guidance to address potential bias and conflicts of interest in clinical investigations

Sidley Austin LLP
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USA
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March 1 2013

FDA has finalized its guidance on financial disclosure for clinical investigators. A draft of the guidance, published in May 2011, was developed in

Increased FDA scrutiny of pre-approval communications continued in 2012

Sidley Austin LLP
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USA
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February 5 2013

Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA's

FDA releases draft guidance concerning clinical trials

Sidley Austin LLP
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USA
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December 6 2012

On November 20, the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials

FDA issues warning letter to Lancôme for anti-aging claims

Sidley Austin LLP
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USA
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September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics

New Chinese medical device GCP unveiled for public comments

Sidley Austin LLP
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China
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September 4 2012

The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012

Stem cell warning letter reflects FDA focus on medical procedures

Sidley Austin LLP
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USA
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April 9 2012

On March 13, 2012, the compliance office within the Center for Biologics Evaluation and Research (CBER) at FDA sent a Warning Letter to IntelliCell Biosciences, Inc., alleging that the firm’s IntelliCell process, based on acquiring adipose-derived stem cells and resulting in stromal vascular fraction, is a biological drug regulated under the Federal Food, Drug, and Cosmetic Act

FDA announces plans for 510(k) reform and plans to issue key guidance in 2011

Sidley Austin LLP
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USA
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January 21 2011

On January 19, 2011, FDA released its plan of action for improving the 510(k) program, the most common review pathway for medical devices

Senate passes food safety legislation: food product and dietary supplement implications

Sidley Austin LLP
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USA
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December 7 2010

On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote

FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications

Sidley Austin LLP
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USA
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November 19 2010

The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first substantive guidance from FDA on this issue

FDA seeks to clarify when study sponsors do not need INDs

Sidley Austin LLP
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USA
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October 28 2010

FDA issued a draft guidance in response to “frequent inquiries” from both the academic research community and the pharmaceutical industry on a “range of issues” relating to the application of the Agency’s Investigational New Drug (IND) requirements