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Expertise in all things FDA
Pete Rutkowski
- Diane McColl will be presenting at the National Restaurant Association's Nutrition Executive Study Group Annual MeetingMarch 16th, 2016
Network with restaurant nutrition professionals who face the same challenges, and share on-target, specialized experiences. What better way to discover best practices, solutions to stubborn problems, or opportunities for advancement than from restaurant leaders in your field? Our Nutrition Executive Study Group delivers information essential …
- Alan Kirschenbaum is presenting at the American Pharmacists Association APhA Annual MeetingMarch 4th, 2016
Dr. Rajiv Shah will deliver his keynote presentation on “Pharmacists Improve Care Through Team Collaboration.” Dr. Shah will inspire you with stories of how disruptive health care galvanizes patients, physicians, and pharmacists to work together. Dr. Shah is a strong advocate for pharmacists, especially as …
- John Fleder is a Panelist at the DIA Marketing Pharmaceuticals 2016 ConferenceMarch 2nd, 2016
Bethesda North Marriott Hotel & Conference Center, North Bethesda, MD Thursday, March 3, 2016 8:45 am _ 10:30 am Now in its 27th year, the DIA Marketing Pharmaceuticals 2016 Planning Team created a program that celebrates the conference components attendees look forward to each year while INCREASING the …
- Ricardo Carvajal is presenting at the GMA Legal Conference Setting the Bar for Foods Beverage and Consumer Goods LawFebruary 23rd, 2016
The GMA Legal Conference is the preeminent gathering for consumer packaged goods professionals exclusively focused on issues that affect food, beverage and consumer product manufacturers. Top in-house counsel, defense attorneys and regulatory experts will cover a wide array of legal topics, with an emphasis on …
- Karla Palmer is speaking at the FDLI – Drug Quality and Security in 2016February 23rd, 2016
- Ricardo Carvajal is presenting at the Tulane Environmental Law and Policy SummitFebruary 19th, 2016
21st Annual Summit on Environmental Law & Policy February 19-20, 2016 Tulane Environmental & Energy Law Society is proud to present the twentieth annual Summit on Environmental Law & Policy, to be held February 19-20, 2016, at Tulane University Law School in New Orleans, Louisiana. This …
- HPM issues summary and schedules webinar on Medicaid Rebate final ruleFebruary 19th, 2016
- Alan Kirschenbaum and Michelle Butler are presenting at the Medical Foods Regulation WebinarFebruary 19th, 2016
Friday, February 19th 1:00 – 3:00 PM ET Speakers: Michelle Butler, Director, HP&M Alan Kirschenbaum, Director, HP&M Jennifer Lospinoso, Director, Advisory, KPMG LLP Timothy Nugent, Managing Director, KPMG LLP
- Commercialisation of Healthcare Global GuideJanuary 19th, 2016
Additional information available here.
- FDLI Introduction to Law and Regulation Drug and Medical Device: The New Approval Process: NDA Submission and ReviewNovember 9th, 2015
Introduction to Law and Regulation _ Drug and Medical Device November 9-10, 2015 | Gordon & Rees LLP | San Francisco, CA This unique combination course will give participants a comprehensive overview of the laws and Food and Drug Administration (FDA) regulations affecting …
- James Valentine will be presenting at the FDLI training course on Introduction to Law and Regulation – Drug and Medical DeviceNovember 9th, 2015
Introduction to Law and Regulation – Drug and Medical Device November 9 – 10, 2015 Gordon & Rees LLP 275 Battery Street, Suite 2000 San Francisco, CA 94111
- A Matter of Substantial Discretion: A Recent Rift between DEA and Its ALJs Could Significantly Impact RegistrantsNovember 1st, 2015
The Federal Controlled Substances Act (CSA) and regulations promulgated by the Drug Enforcement Administration (DEA) provide for the adjudication of administrative actions involving entities registered to handle controlled substances. DEA annually adjudicates dozens of matters, the majority of which involve determining whether a party should be …
- Serra Schlanger is speaking at 2015 NAHC Annual MeetingOctober 30th, 2015
- Jamie Wolszon is speaking at the Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics ConferenceOctober 14th, 2015
October 14-15, 2015 | Alexandria, VA ABOUT THE CONFERENCE As innovation continues to evolve and diagnostic tests advance in their complexity, the challenge in assuring regulatory approval increases in tandem. Manufacturers face numerous hurdles in defining clinical evidence to support and secure timely regulatory approval in an …
- Diane McColl is presenting at the Food Law for In-House Counsel and Regulatory ProfessionalsOctober 7th, 2015
Food Law for In-House Counsel and Regulatory Professionals October 7-8, 2015 This workshop has been specially designed for industry professionals to gain a foundational level of understanding of the legal and regulatory issues revolving around the ever-changing area of food law. This comprehensive two-day workshop will feature …
- Thomas Reuters Commercialisation of HealthcareOctober 1st, 2015
Thomson Reuters Book: Commercialisation of Health Care, Second Edition, October 2015 Additional information available here.
- Amarin Case Tests Limits of FDA Regulation of Off-Label PromotionOctober 1st, 2015
- Kurt Karst is presenting at the FDA Boot CampSeptember 30th, 2015
DoubleTree Suites by Hilton Times Square New York, New York Get the ultimate roadmap to the complicated landscape of FDA regulatory law The approval process&pre-approval concerns&product labeling& clinical trials&adverse events reports& patent concerns& exclusivity all are critical aspects in the commercialization process for drugs, biologics, and devices which …
- Wes Siegner is presenting at the ACC Mountain West Chapter Annual Nutrition Law SymposiumSeptember 25th, 2015
Please join the ACC for our Eleventh Annual Nutrition Law Symposium & EU Food and Consumer Law Workshop Friday, September 25th, 2015 The Garden Room at Thanksgiving Point Gardens 3900 North Garden Drive Lehi, UT 84043 EU Food & Consumer Law Workshop: 7:30 a.m. Registration and Breakfast 8:00 a.m. “How to adapt a …
- Summary of HRSA 340B Proposed GuidanceSeptember 3rd, 2015
- Medical Food and Prescription Meals Industry Conference and ExpoAugust 6th, 2015
MFICE (Miami) brings you highly qualified experts to speak about medical meals and prescription foods at this event. The presentations will be focused on improving the field. Each presenter will be both objective and neutral. Those interested in speaking at this event please contact us …
- Outcome of LDT Regulation Controversy Defies ForecastingJuly 21st, 2015
- Room for Flexibility in FDA’s “Gold Standard” of Drug ApprovalJuly 16th, 2015
Additional information available here.
- Riette van Laack will be presenting at the Pre-IFT15 Short Course _ Labeling Requirements and Implications for Foods Marketed in the U.S.July 9th, 2015
Labeling a food product properly is as important to its legal compliance as manufacturing. Through this introductory course, participants will examine the legal naming of a food product, listing its ingredients (such as flavors), presenting its nutritional details, and making claims related to nutrient content, …
- Diane McColl and Ricardo Carvajal are presenting at the Grocery Manufacturers Association, Webinar: Emerging Issues: PHOs-Since WWI…So WhyJuly 7th, 2015
1 to 2:30 pm FDA has announced their Notice of Final Determination… …Stating that Partially Hydrogenated Oils (PHOs) in processed food are no longer “generally recognized as safe” (GRAS) based on the findings of the Institute of Medicine (IOM) review of the scientific evidence and the expert …
- James Valentine is presenting at the DIA 2015 Annual Meeting: "The Growing Role of the Patient Leading Into PDUFA VI: Negotiations and 2016"June 15th, 2015
The DIA 2015 51st Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines come together each June all with a common goal to foster innovation that will lead to the development …
- Kurt Karst is presenting at the Drug Information Association: Annual MeetingJune 14th, 2015
The DIA 2015 51st Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines come together each June all with a common goal to foster innovation that will lead to the development …
- Alexander Varond will be presenting at the DIA 2015 Annual MeetingJune 14th, 2015
The DIA 2015 51st Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines come together each June all with a common goal to foster innovation that will lead to the development …
- Michelle Butler is presenting at the 2015 FDA-OCRA Annual Educational Conference, Reg Affairs DiscussionJune 3rd, 2015
June 3 is Plenary Sessions in AM and Three Breakouts in the PM: 1. Clinical Trials Breakout Sessions – Back by Popular Demand 2. International Breakout Sessions – New Breakout Session 3. Dietary Supplements Breakout Sessions June 4 is Half Day Breakout Sessions in the AM 1. Medical Devices and …
- James C. Shehan is presenting at the Academy of Managed Care Pharmacy Webinar – Current Constructs for MCO Speciality Decision Making, DocumentationJune 2nd, 2015
Academy of Managed Care Pharmacy Webinar _ Current Constructs for MCO Specialty Decision Making, Documentation and Transparency _ What are the Components that Change with Biosimilars?; 1 pm
- Jennifer Newberger is presenting at the ABA Family Law 2015 Spring CLE ConferenceMay 6th, 2015
May 6-9, 2015 Park Hyatt Aviara 7100 Aviara Resort Drive Carlsbad, CA 92011
- Riette van Laack will be presenting at the Protein Trends & Technologies SeminarMay 5th, 2015
Pre-Conference Program: Business Strategies. This day will focus on fundamental and ever-changing factors impacting the global protein ingredient market. The information is crucial for anyone guiding their protein ingredient business or for those where the protein ingredient marketplace has significant impact on their business. Examples of …
- Kurt Karst is speaking at the RDD Europe 2015May 5th, 2015
The meeting format will include: • In-depth discussions of the developing issues surrounding aerosol drug delivery including new therapeutic opportunities and drug design technologies, progress in drug development alongside novel in vitro and in vivo testing methods, regulatory science… and much more. • Scientific Poster Sessions covering …
- Bob Dormer is presenting at the Florida Medical Manufacturers ConsortiumMay 4th, 2015
The 2015 Florida Medical Device Symposium will be held May 4-5, 2015, at the Hilton Carillon Park in St. Petersburg. The symposium is Florida’s premier event for medical device manufacturing firms, featuring nationally recognized speakers, expert panels on regulatory issues and industry trends, legislative updates …
- Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory ScienceApril 27th, 2015
Sasinowski, F., Panico, E. & Valentine, J., “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory Science, vol. 49(5), 680-697 (2015). The Drug Information Association journal, Therapeutic Innovation and Regulatory Science, published the findings of …
- Diane McColl is presenting at the Food Hydrocolloid ConferenceApril 26th, 2015
Miami, Florida – April 26-28
- Jeff Gibbs is speaking at the AMDM Annual ConferenceApril 22nd, 2015
Bethesda North Marriott Hotel and Conference Center 510(k) Submissions Workshop, April 20-21, 2015 Pre-Submissions Workshop , April 21, 2015 AMDM Annual Meeting, April 22-23, 2015
- Bringing Your Pharmaceutical Drug to MarketApril 1st, 2015
David Clissold and James Valentine* co-authored Chapter 3-1, “FDA Regulatory Scheme” and Alexander Varond authored Chapter 3-7, “Orphan Drugs” in the Food and Drug Law Institute’s guidebook Bringing Your Pharmaceutical Drug to Market. Both chapters cover essential elements of development and approval of pharmaceutical products in …
- Riette van Laack will be presenting at the Spring Short Causes 2015March 25th, 2015
What Labeling Requirements and Implications for Foods Marketed in the U.S. When March 25-26, 2015 Where Hyatt Regency Orange County 11999 Harbor Boulevard Garden Grove, California Description Event – General Information Labeling Requirements and Implications for Foods Marketed in the U.S. Event Website URL Through this introductory course, participants will examine the legal naming of …
- A Warning Letter on FDA’s Expansive Interpretation of Its Facilities – Inspection AuthorityMarch 13th, 2015
In this Legal Backgrounder published by the Washington Legal Foundation, HPM authors write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices. This article addresses several of the unresolved questions regarding FDA’s inspection authority and aggressive inspection practices, as discussed in FDA’s …
- Anne Walsh is presenting at the Forum on Fraud and Abuse in the Sales and Marketing of Medical DevicesMarch 12th, 2015
Program Description Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on the changing trends in enforcement, litigation, and compliance. Across all agency-regulated products, the Food and Drug Administration (FDA) is expected to continue its heightened enforcement efforts. The …
- Kurt Karst is speaking at the FDA Boot CampMarch 10th, 2015
Doubletree Suites by Hilton Times Square 1568 Broadway New York, NY 10036 Now in its 24th iteration, FDA Boot Camp is the premier event that will provide you with the ultimate roadmap to the complicated landscape of FDA regulatory law. ACI’s FDA Boot Camp has been designed by leading …