July 28, 2014

Biotechnology, Food & Drug Administration FDA News

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The National Law Review includes articles impacting the biotech and cleantech fields addressing: licensing and patent issues, intellectual property due diligence, litigation and tax. Content is also included addressing: greenhouse gas (GHG) regulation; mandated emissions reduction legislation; NEPA and CEQA claims, common law nuisance litigation; acquiring and selling emission offset and emission reduction credits and acid rain allowances under the United States Clean Air Act, SCAQMD RECLAIM and other air credit programs.

Title Organization Date Postedsort icon
The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors Drinker Biddle & Reath LLP 7/25/2014
FDA Accepts the First Biosimilar Application under the BPCIA (Biologics Price Competition and Innovation Act) Sterne, Kessler, Goldstein & Fox P.L.L.C. 7/24/2014
Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies Drinker Biddle & Reath LLP 7/24/2014
China Releases New Notification Procedures for Class I Medical Devices Covington & Burling LLP 7/24/2014
Illinois Legislature Approves Medical Marijuana for Epileptic Adults and Children Heyl, Royster, Voelker & Allen, P.C. 7/23/2014
New Food Safety Law for China Covington & Burling LLP 7/23/2014
Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter Morgan, Lewis & Bockius LLP 7/22/2014
FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms McDermott Will & Emery 7/22/2014
China's Legislature Releases Draft Food Safety Law for Public Comment Covington & Burling LLP 7/18/2014
Food and Drug Administration (FDA) Releases Draft Guidance on Benefit and Risk Analysis for 510(k)s Barnes & Thornburg LLP 7/18/2014
FDA Grapples with Nanotechnology Covington & Burling LLP 7/18/2014
FSIS (Food Safety and Inspection Service) Proposes New Recordkeeping Requirements for Ground Beef Processors/Retailers Morgan, Lewis & Bockius LLP 7/17/2014
Summary Judgment Was Properly Granted In Favor Of Employer In Off-The-Clock Overtime Case Proskauer Rose LLP 7/15/2014
Sugar and Spice and Cases on Ice: Evaporated Cane Juice Case Stayed Until FDA Issues Formal Guidelines Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 7/14/2014
Proposed Expanded Definition of Waters of the United States [VIDEO] Allen Matkins Leck Gamble Mallory & Natsis LLP 7/14/2014
New York Becomes 23rd State to Enact Medical Marijuana Law Jackson Lewis P.C. 7/10/2014
PTO Litigation Center Report – July 10, 2014 Sterne, Kessler, Goldstein & Fox P.L.L.C. 7/10/2014
Confronting Apocalyptic Risks of Broken Antibiotics Pipeline Covington & Burling LLP 7/9/2014
Food and Drug Administration (FDA) Issues Two Additional Draft Guidance Documents on Social Media Katten Muchin Rosenman LLP 7/8/2014
First Written Decision Pertaining to Pharmaceuticals Armstrong Teasdale 7/7/2014
Abbvie V. Janssen Biotech –Written Description Requirement Road Map Schwegman, Lundberg & Woessner, P.A. 7/7/2014
EEOC Letter Finds Genetic Information Non-Discrimination Act (GINA) and Americans with Disabilities Act (ADA) Issues in Fit-for-Duty Medical Examination Form Jackson Lewis P.C. 7/7/2014
Patent Trial and Appeal Board (PTAB) Permits Substitution of New Claims in Challenged Patent McDermott Will & Emery 7/2/2014
Courts In 9th Circuit Continue To Split On Ascertainability: “All Natural” Class Action Dies On the Vine But Sexual Energy Supplement Suit Has Staying Power Proskauer Rose LLP 7/2/2014
Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., Order Regarding Time Bar For Filing IPR IRP2014-00360 Drinker Biddle & Reath LLP 7/2/2014
More Questions Than Answers from the Patent and Trademark Office (PTO) Schwegman, Lundberg & Woessner, P.A. 7/2/2014
FDA Warns of Rare but Potentially Severe Side Effects in Acne Drug Products Greenberg Traurig, LLP 7/2/2014
New Alcohol and Tobacco Tax and Trade Bureau (TTB) FAQs on Sugar Claims McDermott Will & Emery 7/2/2014
Examining the Impact of the Supreme Court's Limelight v. Akamai Decision [VIDEO] Sterne, Kessler, Goldstein & Fox P.L.L.C. 7/2/2014
New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 7/2/2014
FDA Issues Guidance for Safety of Nanomaterials in Cosmetic Products (as well as in Food) Greenberg Traurig, LLP 7/2/2014
Nanotechnology in Food Production: FDA Finalizes Guidance on Manufacturing Process Changes for Food Additives Michael Best & Friedrich LLP 7/1/2014
New York State Legislature Approves Use of Medical Marijuana; Users to Be Considered "Disabled" Under State Human Rights Law Proskauer Rose LLP 7/1/2014
FDA (Food and Drug Administration) Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media Covington & Burling LLP 7/1/2014
Energy & Environmental Law Update - June 30, 2014 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 7/1/2014
FDA Gives an Inch, But Only an Inch, on Use of Social Media to Promote Drugs and Devices Barnes & Thornburg LLP 6/30/2014
FDA Issues Guidance on Use of Nanotechnology in Foods Barnes & Thornburg LLP 6/30/2014
Trademark Rights around the World: It May Be BUDWEISER® in the US, But Not Everywhere Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 6/30/2014
Supreme Court: Food, Drug, and Cosmetic Act (FDCA) Compliance Does Not Bar Lanham Act Claims - POM Wonderful LLC v. Coca-Cola Co. McDermott Will & Emery 6/30/2014
Comment Period Closing Soon on New Food and Drug Administration (FDA) Food Transport Rule Beveridge & Diamond PC 6/28/2014
FDA Draft Guidance - Best Practices for Developing Drug Trademarks - Food and Drug Administration Sterne, Kessler, Goldstein & Fox P.L.L.C. 6/27/2014
Federal Judge Puts Narcolepsy Drug Horizontal Conspiracy Claims to Bed McDermott Will & Emery 6/27/2014 Files False Advertising Action Over Competitor's Online Dietary Supplement Offerings and Claims Womble Carlyle Sandridge & Rice, PLLC 6/26/2014
Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device Manufacturers Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 6/26/2014
Is an Abbreviated Pathway for Biosimilars Coming Soon to China? Michael Best & Friedrich LLP 6/25/2014
Food and Drug Administration (FDA) Relaxes Regulation of Certain Software Devices Covington & Burling LLP 6/24/2014
Food and Drug Administration (FDA) to Cease Active Regulation of Medical Device Data Systems (MDDS) and Other Health IT Devices Morgan, Lewis & Bockius LLP 6/24/2014
340B Registration Changes: Re-enrollment of Currently Participating Facilities and Eligibility Based on Amended Cost Reports McDermott Will & Emery 6/23/2014
Food and Drug Administration (FDA) Issues Draft Guidance Docs On How To Provide Accurate Risk/Benefit Info in 140 Characters Or Less And Clean Up 3rd Party UGC [129/140] Proskauer Rose LLP 6/23/2014
FDA Issues Draft Guidance Easing Compliance for Medical Device Data and Image Systems - Food and Drug Administration Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 6/20/2014

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