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Drug Approval Master Class


Level: Advanced
Runtime: 92 minutes
Recorded Date: September 27, 2018
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Agenda


  • Introduction to FDA
  • History of the Food and Drug Administration
  • NDA Approval Process
  • Pre-Clinical Research
  • Laboratory and Animal Studies
Runtime: 1 hour and 32 minutes
Recorded: September 27, 2018

Description

Our expert speakers in this Drug Approval Master Class will provide an overview of the laws, regulations, and guidance applicable to prescription drug testing, approval, manufacturing, and commercialization, as well as current enforcement trends.

Pharmaceutical manufacturers are again capturing headlines with new drugs that are transforming medical care. The FDA remains the gatekeeper for these products. Advising manufacturers (or any entity in the healthcare industry) requires a keen understanding of the FDA and its approval and oversight processes. Join us as we hear from experienced practitioners about key topics in this continually evolving practice area.

This program was recorded on September 27th, 2018.

Provided By

American Bar Association

Panelists

David S. Weinstock

Attorney
Law Office of David S. Weinstock

David S. Weinstock is a versatile attorney with an entrepreneurial mindset and a global perspective who achieves success using strategic and analytical problem solving strategies, combined with technical knowledge and organizational skills, to support pharmaceutical, biologic, biotech and medical device product development, manufacturing and marketing.

Linda Pissott Reig, Esq.

Shareholder
Buchanan Ingersoll & Rooney PC

Linda Pissott Reig focuses her practice on the life sciences industry. She has extensive experience with the laws and industry standards that apply to the marketing and sale of pharmaceuticals, medical devices, biologics, dietary supplements and medical foods.

Linda co-chairs the firm’s FDA Section. She joined Buchanan Ingersoll & Rooney after having previously served as a principal for a New Jersey–based law firm, and Vice President, Compliance Services of its pharmaceutical services subsidiary.

Linda counsels companies on lawful marketing and sale of FDA–regulated products. She reviews promotional materials (including broadcast ads, print materials, internet/social media) and evaluates marketing initiatives, such as physician speaker programs and patient support groups. For companies awaiting FDA approval, she provides guidance on lawful preapproval communication strategies.

In addition, Linda advises on compliance with industry standards for clinical trial set-up and oversight, including recruitment of investigators and subjects. She conducts compliance training for life sciences companies on compliance topics.

She prepares Standard Operating Procedures and Policies for corporate compliance programs, negotiates and drafts agreements and advises on consulting arrangements with key opinion leaders. In addition, she advises on pharmacovigilance, advisory boards, continuing medical education grants, charitable contributions and labeling changes. Linda guides companies on how to minimize legal risk while achieving business objectives.

On the state law side, Linda assists companies with their state law obligations, such as aggregate spend, marketing disclosures, data-mining, clinical trial disclosure, adherence to compliance codes, sales representative licensure and manufacturing/distribution licensure.

Linda serves as co-chair of the BioNJ Legal, Compliance and Regulatory Advisory Committee, which she was instrumental in forming in 2008. The committee is comprised of in-house counsel and compliance representatives from top-ranking NJ-based biotechnology companies who discuss new legal developments and put together programs of interest to the NJ-based biotechnology community.


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