Search results
Order by most recent / most popular / relevance
Results: 1-10 of 16
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FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications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The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first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New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products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
FDA shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update
- Sidley Austin LLP
- -
- USA
- -
- July 15 2011
On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types
New draft guidance on companion diagnostics signals new responsibilities for pharma and dx companies and clinical laboratories
- Sidley Austin LLP
- -
- USA
- -
- July 26 2011
On July 14, U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance on In Vitro Companion Diagnostic Devices
FDA draft guidance on mobile apps signals increased regulatory oversight
- Sidley Austin LLP
- -
- USA
- -
- July 27 2011
On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices
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
Current Search
- Author - Coleen Klasmeier
- Workarea - Product Liability
- Workarea - Healthcare
Suggested Facets
Author
- Allison Fulton (1)
- Gail H. Javitt (3)
- James C. Stansel (3)
- Jeffrey M. Senger (1)
- Lauren R. Silvis (3)
- Paul E. Kalb, M.D (1)
- Raymond A. Bonner (10)
- Scott Bass (4)
- Torrey A. Cope (1)