Archives -- Drugs & Biologics

Articles & Publications

FDAAA – An Abbreviation in Search of Understanding:  A Review of Selected Drugs and Biologics  Provisions of the Food and Drug Administration Amendments Act of 2007.  RAPS Focus 13(2),  27-33,  2008.  Click here for article.


Western States Medical Center – Supreme Court Reins FDA in on Regulating Commercial Speech,  Drug Delivery Technology, July 2002.


Electronic Signatures Act – Feast or Famine for FDA-Regulated Industries?  Swit, M and Edson, J.  FDLI Update, January 2001.


Profitability, Patient Populations and the Orphan Drug Act – or – “Should an Orphan Have the Right to More Than One Parent?”  Food, Drug, Cosmetic and Medical Device Law Digest, New York State Bar Association, Food, Drug and Cosmetic Law Section, January 1992.   Click here for article.

Presentations & Panel Discussions

Critical Legal Issues Facing Drug GMP Compliance.  23rd Annual GMP By The Sea Conference.  August 27, 2018.  Cambridge, MD. 


FDA Regulation of Drug Manufacturing.  Food & Drug Law Institute. Introduction to US Drug Law and Regulation.  July 25, 2018. San Francisco.


Combination Products, OTC Drugs, and Orphan Drugs.  Regulatory Affairs Certification (RAC) Review Course. San Diego Regulatory Affairs Network (SDRAN).  July 26, 2018. Webinar.


Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments  for Orphan and Rare Diseases. Orphan Drugs & Rare Diseases -- 2018 Americas West Coast. June 25, 2018.  San Diego, CA.


Transitioning to Non-Orphan Indications for Orphan Drugs. Moderator, Panel Discussion

Orphan Drugs & Rare Diseases -- 2018 Americas West Coast. June 26, 2018.  San Diego, CA.  [no slides] 


Regulation of Combination Products, Orphan Drugs, and OTC Drugs. SDRAN RAC Review Course.  July 2017. San Diego.   


Regulation of Combination Products, Orphan Drugs, and OTC Drugs. SDRAN RAC Review Course. July 20, 2016. San Diego.      


Generic Drugs and Biosimilars.  SDRAN RAC Review Course. June 16, 2016.  San Diego.


Alternative Approaches to FDA Approval for Drug and Device Firms.  Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference.  May 6, 2016. Irvine, CA.   


Biosimilars:  Beginning a Conversation. Panel Discussion at JADPRO LIVE Conference.  November 7, 2015. Phoenix, Arizona. [panel; no slides]


ANDAs, OTCs, and Orphan Drugs.  SDRAN RAC Review Course. June 24, 2015. San Diego.   


Alternative Approaches to FDA Approval for Drug and Device Firms. San Diego Regulatory Affairs Network. February 12, 2015.  


Key FDA Challenges in Bringing Orphan Drugs to the Market in the U.S. SABPA 4th Annual Medical Devices & Diagnostics Summit.  February 7, 2015.  San Diego.   


Alternative Approaches to FDA Approval for Drug and Device Firms. A Compliance2Go Webinar. January 29, 2015.   


ANDAs, OTCs, Orphans and Cosmetics. SDRAN RAC Review Course. August 6, 2014. San Diego.


Orphan Drug Regulation. 2nd Annual Orphan Drugs Research & Commercialization Conference.
GTCBio.  Feb. 20-21, 2014. San Diego, CA. [panel; no slides].


U.S. Regulation of Biosimilars.  2nd Annual BioSimilars And Follow-On Biologics 2014 Americas Conference. February 10-12, 2014.  Philadelphia.


Creative Strategies in Dealing with FDA for Approval of Drugs and Medical Devices.  PSC Creative Learning Webinar. July 10, 2013.


Regulatory & Quality Considerations in Virtual Drug Development. Strategies for Success in Virtual Drug Development Conference. April 15, 2013, San Diego.


Alternative Approaches to FDA Approval for Drug and Device Firms.  Compliance2Go Webinar. February 21, 2013.


ANDAs, OTCs, Orphans and Cosmetics – Key Issues.  SDRAN RAC Review Course.  August 1, 2012. San Diego.


FDA Regulatory Challenges for Biosimilars and CMOs.  FierceBiotech Webinar.  June 26, 2012.

Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for Pharmaceutical Products.  Moderator.  Drug Information Association (DIA) Annual Conference, Session Chair.  June 26, 2012. Philadelphia. [no slides; moderated panel]


Biosimilars -- Wave of the Future or Child of The Privileged Few?  Licensing Executives Society San Diego Chapter.  February 21, 2012.


Regulatory Considerations in Product Development. LARTA NIH-CAP Commercialization Workshop, November 1, 2011. Los Angeles.


Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governing Therapies for Rare Diseases.  The Weinberg Group Inc. Webinar, February 23, 2011.


Drug Safety – An Overview of FDA Powers under FDAAA.  SDRAN-OCRA Drug Development Conference. November 4, 2009, Carlsbad, CA.


Selected Regulatory Issues in Ophthalmic Drug Development.  5th Annual Ophthalmic Drug and Delivery Summit. Pharmaceutical Education Associates. September 22, 2009, San Diego.


Drug Development.  Moderator, Biotech Vendors Services.  July 22, 2009, San Diego. [no slides]


Drug Safety – Perspectives on Industry’s Duties in the Post-Vioxx Age.  Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference.  June 10, 2009, Irvine, CA.  


Drug Delivery -- Perspectives on the FDA Regulatory Environment.  Third Annual Drug Delivery Summit.  Arrowhead Conferences. May 14, 2009, San Francisco.


Drug Safety:  Perspectives on Industry's Duties in the Post-Vioxx Age.  FDLI Annual Conference.  April 22, 2009, Washington, D.C.


FDA Regulatory Issues and  Ophthalmic Drug Development.   Pharmaceutical Education Associates Ophthalmic Drug Delivery Conference. September 22-24, 2008, San Diego.


FDA Regulatory Considerations for  Life Sciences Companies.  Swedish American Chamber of Commerce. Swedish-American Entrepreneurial Days. April 9, 2008, San Diego.


The Regulatory Horizon.  Keynote presentation at the Pharmaceutical Education Associates’ 2nd Annual Skin Summit Conference, February 20, 2008, Philadelphia.


Key Current Issues In European Regulation.   Pharmaceutical Education Associates Pipeline to Product Conference, November 30, 2007, Alexandria, VA.


Regulatory and Other Pitfalls in Drug Development.  Pharmaceutical Education Associates Pipeline to Product Conference, November 30, 2007, Alexandria, VA.


The Regulatory Horizon.  Keynote Presentation on FDA Regulatory Developments at Pharmaceutical Education Associates Annual Nasal Drug Delivery Conference, October 4, 2007, Philadelphia.


FDA Regulatory Developments.  Keynote Presentation at Pharmaceutical Education Associates
Annual Ophthalmic Drug Delivery Conference, September 10, 2007, San Diego.


Keynote Presentation on FDA Regulatory Developments.  Presented at the  Pharmaceutical Education Associates Annual Drug Delivery Conference, June 6, 2007, San Diego.


The Impact of the Democratic Congress on the Biotech Industry. Moderated Panel at the BayBio Annual Meeting, April 26, 2007, San Francisco. [panel; no slides]


Alternative Approaches to FDA Approval for Drug and Device Firms.  SDRAN, November 28, 2006, San Diego.


Strategies in Designing Clinicals for Fixed-Combination Drugs.  DIA Annual Meeting, June 19, 2006, Philadelphia.


What Should Pharmaceutical Companies Do Now?  Governance and Systems for Drug Safety.  The International Pharmaceutical Compliance Summit on Medical Affairs, Clinical Trials, Safety, and Publication.  March 31, 2005.  Philadelphia, PA.


California Stem Cell Research And Cures Act.  RAPS West Coast Conference & Exhibition, March 22-24, 2005, San Francisco, CA.


Strategies in Designing Clinicals for Fixed-Combination Drugs.  Combination Drug Development Conference sponsored by Barnett International Conferences, March 7-8, 2005, San Diego, CA.


Pharmaceutical Legal and Financial Consequences -- When Risk Management Goes Astray. Pharmaceutical Education and Research Institute (PERI).  "Developing a Risk Management Strategy:  A Hands-On Workshop." November 11, 2004.  Washington, D.C.


FDA Legal and Regulatory Strategies for Start-up Companies.  Tech Coast Angels, BioMedTrak Program, March 2003, La Jolla, CA. 

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