FOOD, DRUG AND COSMETIC LAW ELECTRONIC MATERIALS

FOOD, DRUG & COSMETIC LAW SECTION ANNUAL MEETING: THURSDAY, JANUARY 25, 2018
MCLE MATERIALS


Let’s get started!

Accessing your Electronic Course Materials is just a click away! We encourage your to download the PDF and save to your laptop, tablet, Ipad or other mobile device prior to travelling. 

Click the links below to access your Electronic Course Materials, or

download the full set of materials, here: http://www.nysba.org/FDCAM18Materials/

DOWNLOAD THE MATERIALS BY TOPIC:

Embracing the Continuum of Risk: CTP Builds Policy on Product Standards and Tobacco Flavoring, and Reassesses Regulatory Priorities in Aftermath of the Deeming Rule
Presented by Brian J. Malkin, Esq. (Moderator) , Anne Pierson Allen, Esq. and Christina Young, Ph.D.
*Embracing the Continuum of Risk: New FDA Policies in the Aftermath of the Deeming Rule (Anne Pierson Allen and Christina Young PPT)

Are all Human Drugs Actually Animal Drugs Waiting to Be Developed? What it Takes to Develop a New Animal Drug and Other Animal Health Product Considerations
Presented by Janet Linn, Esq. (Moderator), Manya Deehr, Esq. and Nancy E. Halpern, Esq.
*In-Licensing Human Drug Products For Development in Animal Health – A Cautionary Tale (Manya Deehr PPT)
*Update on Compounding for Animals (Nancy Helpern PPT)

From Farm to Table – The Future of GMO Plants and Animals
Presented bt Suchira Ghosh, Esq. (Moderator), Karen Carr, Esq. and Kristin Landis, Esq.
*Farm to Table: The Future of Biotech Plans and Animals (Karen Carr PPT)
*Bioengineered Food Disclosure Rulemaking Update (Kristin Landis PPT)

Gene Therapies Now FDA-Approved for Use: What You Need to Know to Address Safety and IP Considerations – Plus and Update on Biosimilars
Presented by April Polikoff, Esq. (Moderator), JP Ahluwalia, Ph,D., Janet Linn, Esq. and Vicki Malia-Piekarz, Esq.
*Safety Considerations for CAR T Gene Therapy (JP Ahluwalia PPT)
*Office of NYS Attorney General Health Care Bureau 
*Update on Biosimilars: Sandoz v. Amgen and Marketing Challenges (Janet Linn PPT)
*Intellectual Property Considerations for CAR-T Gene Therapy (Victoria Malia-Piekarz PPT)

Ethics in Early Clinical Trials – How Does an Attorney Balance the Duty to Represent the Client with the “Greater Good” of Early Access and the “Right to Try” that Benefit Patients?
Presented by David S. Weinstock, Esq. (Moderator), Anne Pierson Allen, Esq. and Ilene Wilets, Ph.D.
*Balancing the Ethical Duty of Zealous Representation with the “Greater Good” of Early Access to Investigational Drugs PPT

Opiod Drug Crisis: Measures to Control
**Additional Materials
Presented by Larissa Bergin, Esq. (Moderator), Professor Michael Carrier, Lisa Landau, Esq., James Klaiber, Esq., Michael Knight, Esq. and James Major, Esq.
*Do Laws Mandate Drug Company Collaboration (Michael Knight and Michael Carrier PPT)
*So Sioux Me: Native American Tribal Immunity From PTAB Proceedings & District Court Litigations (James Klaiber PPT)
*Sovereign Immunity and Patents: Here Be Dragons! (James Major PPT)

Innovation and Regulation of Emerging Technologies: Safety and Data Security
FDA’s Evolving Policy on Personalized Medicine Tests
Presented by Christopher C. Palermo, Esq. (Moderator), Nancy L. Perkins, Esq., Mahnu V. Davar, Esq. and Nancy K. Stade, Esq.
*Medical Devices: Innovation and Regulation of Emerging Technologies (Mahnu Davar and Nancy Perkins PPT)
*FDA’s Evolving Policy on Personalized Medicine Tests (Nancy Stade PPT)

Biographies

Annual Meeting Program Agenda

After MCLE program has ended complete the online evaluation.

Download the full set of materials, here: http://www.nysba.org/FDCAM18Materials/

Please note that this download will take awhile due to the large volume of material, depending on your internet connection.