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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FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications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The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first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
New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products
- Sidley Austin LLP
- -
- USA
- -
- June 16 2011
In a new proposed guidance, FDA has signaled its intention to shift responsibility for the use of certain medical devices from customers to manufacturers, based on an expansive and legally questionable presumption of “intent.”
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
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 request for comments on timing for implementation of safety labeling changes
- Sidley Austin LLP
- -
- USA
- -
- January 4 2012
On December 20, 2011, the U.S. Food and Drug Administration (FDA) published a notice requesting public input on the deadlines for implementing drug safety labeling changes
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
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