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Daniel A. Kracov Document Search Results (5) Sort by:  | FDA’s Draft Biosimilars Guidance Documents: Overview and Implications
Kenita Barrow, Joshua M. Glasser, Daniel A. Kracov; Arnold & Porter LLP;
Legal Alert/Article February 23, 2012, previously published on February 2012 On February 9, 2012, the US Food and Drug Administration (“FDA” or “the Agency”) released for comment its initial draft guidance implementing the Biologics Price Competition and Innovation Act (BPCIA), signed into law as part of the Affordable Care Act, which creates an...
| | FDA Proposes a Restrictive Framework for Contacts Regulating Requests for Medical Product Information
Mahnu V. Davar, Jeffrey L. Handwerker, Daniel A. Kracov, Marissa Styne; Arnold & Porter LLP;
Legal Alert/Article January 19, 2012, previously published on January 2012 On December 30, 2011, the US Food and Drug Administration (FDA) released for public comment a draft guidance titled, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (Draft Guidance).1 The Draft Guidance provides FDA’s...
| | Potential Changes to US Federal Common Rule May Have Important Implications for Health Information Management In Clinical Trials
Mahnu V. Davar, Daniel A. Kracov, Nancy L. Perkins; Arnold & Porter LLP;
Legal Alert/Article September 12, 2011, previously published on September 2011 On July 26, 2011, the US Department of Health and Human Services (HHS) announced its intention to modify current regulations (the “Common Rule”) governing human research subject protections. The advanced notice of proposed rulemaking (ANPR) poses several possible changes to the Common...
| | The Institute of Medicine Report on the FDA 510(k) Device Clearance Process: Dead on Arrival or Foundation for a New Regulatory Framework?
Daniel A. Kracov, Vernessa T. Pollard, Alex Toy; Arnold & Porter LLP;
Legal Alert/Article August 11, 2011, previously published on August 2011 In light of questions regarding the ability of the 510(k) process to protect patients, and complaints that the process has become too burdensome and time-consuming, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to conduct an extensive evaluation of the...
| | Supreme Court Rules in Favor of Generic Drug Preemption
Anand Agneshwar, Ethan P. Greene, Daniel A. Kracov, Benjamin H. Wallfisch; Arnold & Porter LLP;
Legal Alert/Article July 8, 2011, previously published on July 2011 On June 23, 2011, the United States Supreme Court held in Pliva, Inc. v. Mensing that federal drug labeling laws directly conflict with, and therefore impliedly preempt, state law failure-to-warn claims against generic drug manufacturers. Mensing is the latest in a series of federal preemption...
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