Search results

Order by most recent / most popular / relevance

Results: 1-10 of 10

House drug safety hearing highlights FDA focus on product safety and supply chain obligation

Sidley Austin LLP
-
USA
-
March 12 2010

On March 10, 2010, Dr Joshua M Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration (FDA), presented testimony at the House of Representatives' Committee on Energy and Commerce, Subcommittee on Health hearing on drug safety

New House bill proposes FDA authority to require drug sponsors to develop companion diagnostics

Sidley Austin LLP
-
USA
-
June 11 2010

On May 27, 2010, Representatives Patrick Kennedy (D-RI) and Anna Eshoo (D-CA) introduced HR 5440, the Genomics and Personalized Medicine Act of 2010

FDA reopens comment period to address oversight of laboratory-developed tests

Sidley Austin LLP
-
USA
-
August 24 2010

Last week the U.S. Food and Drug Administration (FDA or the Agency) announced that it would reopen the comment period until September 15, 2010 to provide additional time for stakeholders to submit commentsand to update already submitted commentsregarding the Agency’s oversight of laboratory developed tests (LDTs) (75 FR 5120

FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications

Sidley Austin LLP
-
USA
-
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The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first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

GAO report on food labeling might signal renewed FDA resistance to qualified health claimsglobal life sciences: US-FDA update

Sidley Austin LLP
-
USA
-
January 24 2011

On January 14, 2011, the U.S. Government Accountability Office (GAO) issued a report entitled, “Food Labeling: FDA Needs to Reassess its Approach to Protecting Consumers from False or Misleading Claims,” regarding the use of qualified health claims and structurefunction claims for food products

FDA issues draft guidance on medical device studies

Sidley Austin LLP
-
USA
-
November 18 2011

On November 10, 2011, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents with the stated purpose of encouraging medical device research and innovation of significant risk medical devices

FDA announces two pilot projects for improving ways to trace sources of foodborne illness; FDA will solicit stakeholder input in designing and implementing the pilots

Sidley Austin LLP
-
USA
-
September 15 2011

On September 7, 2011, the U.S. Food and Drug Administration (FDA) announced that it is moving forward with two pilot projectsone for processed foods and the other for producedesigned to help the agency and the food industry, including farms, restaurants, and grocery stores, more rapidly and effectively trace products back to a contamination source during outbreaks of foodborne illness

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

Sidley Austin LLP
-
USA
-
December 7 2010

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

New Chinese medical device GCP unveiled for public comments

Sidley Austin LLP
-
China
-
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

FDA issues warning letter to Lancôme for anti-aging claims

Sidley Austin LLP
-
USA
-
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