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Special Report: The Hot-ish Swag at LegalTech New York 2015
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Waldman: Stop Immunizing Websites That Allow Harassment
A Moment of Simple Justice - Snitching Ain't Easy
Data Privacy: The Next Frontier of Corporate Compliance
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After SoundCloud & Wunderlist: How Berlin plans to grow its startup scene
Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
Diversity and Technology in Focus for Morgan Lewis's Incoming Chair
PREVENTING AND RESPONDING TO DATA BREACHES IN AN ERA OF CYBER INSECURITY
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
A Moment of Simple Justice - Revenge Porn
Why Cyber Security?
How Fenwick Partners Caught the Tech Wave
How is Graphene Currently Used and What is the Hope for the Future?
What is Graphene? Fenwick Patent Attorney Has the Answer
This Week: Ways and Means Advances Four Health-Related Measures... Senate Commerce Committee Clears Legislation on E-Cigarette Packaging... CMS Pushes Back Deadline on Meaningful Use for Physicians....more
The ICO has welcomed a change in legislation which came into effect on 1 February 2015 enabling it to audit National Health Service (NHS) bodies to check for compliance with the UK Data Protection Act 1998. ...more
Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more
So I had an epiphany last night—I was thinking about why more FDA lawyers do not get involved in helping Congress or FDA with developing legislation, regulations, and guidances to help FDA do its business....more
This Week: Upcoming Hearing: HHS Sec. Burwell Appearing Before E&C Committee on FY2016 Budget... CMS Issues 2016 Payment and Policy Updates for Medicare Health and Drug Plans... CMS Releases Improved Rating System for Nursing...more
The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under...more
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more
The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more
Accessories are an everyday reality for almost all users of technology products today. They can help improve efficacy, increase usability and make many other improvements to the technology we use. Increasingly, accessories...more
On February 09, 2015, the FDA issued final guidelines to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more
On February 6, 2015, the United States Food and Drug Administration (FDA) issued long-awaited proposed regulations to implement portions of the Medicare Modernization Act of 2003 (MMA). Consisting of almost one hundred pages...more
The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare...more
The first Untitled Letter of 2015 from the Office of Prescription Drug Promotion (OPDP) provides valuable lessons on drug promotion.
OPDP issued its first Untitled Letter of 2015, after a 2014 relatively light on...more
Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) provided the agency’s new...more
the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more
Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more
The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more
San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and...more
The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more
On February 4, 2015, FDA released draft guidance around its “Expanded Access” program, also known as “compassionate use.” The guidance proposes a greatly streamlined application form that physicians may use on behalf of...more
2015 has been a busy year for the Food and Drug Administration (FDA). In January, the FDA issued guidance documents addressing wellness applications as well as accessories to medical devices and it looks like the...more
In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more
On February 9, 2015, the United States Food and Drug Administration (FDA) issued a final guidance document describing the Agency’s intention not to enforce regulatory controls applicable to medical device data systems (MDDS),...more
Patients who are at high risk for developing blood clots are regularly given inferior vena cava filters in Chicago hospitals and around the nation. While the filters have been used for years in this application, recent...more
On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more
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