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Barnes & Thornburg LLP Columbus, OH Document Search Results (21) Show: results per page Sort by:  | FDA Issues Guidance on Risk-Benefit Determinations for New Medical Devices
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article April 2, 2012, previously published on April 2, 2012 The FDA recently issued a final Guidance titled, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.” The purpose of the Guidance is “to provide greater clarity for FDA reviewers and industry regarding the...
| | FDA Discloses Method for Classifying Food Facilities as "High Risk" Under FSMA
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article March 29, 2012, previously published on March 27, 2012 The Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, requires FDA to inspect food facilities on different time tables depending on whether a facility is classified as “high risk” or not. High-risk facilities must be inspected at least once within the...
| | FDA Issues Guidance on IRB Continuing Review Responsibilities
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article March 12, 2012, previously published on March 9, 2012 The FDA recently issued a final Guidance titled, “IRB Continuing Review after Clinical Investigation Approval.” The purpose of the Guidance is “to assist institutional review boards (IRBs) - by providing recommendations regarding the criteria, process, and frequency of continuing...
| | FDA Updates and Issues Guidance Documents on Food Records in Light of Food Safety Modernization Act
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article March 6, 2012, previously published on February 29, 2012 Another recent Alert noted that the Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, imposes some new and stricter record-keeping requirements on companies in the food supply chain. The FSMA also expanded the FDA’s authority to inspect such records any time the...
|  | FDA Kicks Enforcement Into Higher Gear in FYs 2010 and 2011
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article February 22, 2012, previously published on February 21, 2012 A review of FDA’s published enforcement statistics from fiscal years 2009 through 2011 shows that it has ramped up its enforcement activities in several categories, especially warning letters. The following table compares the numbers by type of enforcement activity over this three year period:
| | FDA Issues Long-Awaited Draft Guidance Documents on Biosimilars
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article February 20, 2012, previously published on February 16, 2012 Ever since the health care reform law was enacted almost two years ago, the biotechnology and pharmaceutical industries have been awaiting the FDA’s release of Guidance documents to describe the “biosimilars pathway,” i.e., the process for bringing to market alternative versions...
| | Key Components of President Obama’s Budget Proposal
Edward Ayoob, Richard R. Boykin, Craig S. Burkhardt, Robert T. Grand, Liz Lopez, D. William Moreau, David Paragas; Barnes & Thornburg LLP;
Legal Alert/Article February 15, 2012, previously published on February 14, 2012 On Feb. 13, 2012, President Barack Obama released his $3.8 trillion fiscal year 2013 (FY13) budget, which over the next decade offers $4 trillion in deficit cuts, including $517 billion in mandatory savings. The budget projects a FY13 deficit of $901 billion or 5.5 percent of the gross domestic...
| | Effective Dates Loom for New Records Requirements Under the Food Safety Modernization Act
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article February 14, 2012, previously published on February 10, 2012 President Obama signed the Food Safety Modernization Act (FSMA) into law on Jan. 4, 2011. The FSMA imposes several extensive new records requirements on food manufacturers and the effective date for some of the more significant new requirements (July 4, 2012) is approaching. The FSMA also gave the...
| | FDA and Medical Devices Industry Reach Tentative Agreement on User Fees
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article February 8, 2012, previously published on February 7, 2012 The FDA recently announced that it has reached a tentative agreement with the medical device industry (represented through trade associations) on user fees, performance goals, and other matters for the period 2013-17. The most touted aspects of the agreement are that (1) user fees will increase...
| | FDA Issues Draft Guidance Mapping 510(k) Review Process
Nicolette R. Hudson, Hae Park-Suk, Lynn C. Tyler; Barnes & Thornburg LLP;
Legal Alert/Article January 13, 2012, previously published on January 6, 2012 The FDA recently issued a draft Guidance titled, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications.” The draft Guidance states that its purposes are “to identify, explain, and clarify each of the critical decision points in the decision-making...
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