Publications

publication February 18, 2021

Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements

‘Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements,’ by Rend Al-Mondhiry, Regulatory Affairs Professional Society (RAPS), June 12, 2019.

publication February 18, 2021

State Regulation of CBD

‘State Regulation of CBD,’ by Rend Al-Mondhiry, April 16, 2019,  Natural Products Insider.

publication January 18, 2021

Teva v. Sandoz: The New Standard of Review in Claim Construction

Teva v. Sandoz: The New Standard of Review in Claim Construction, by Peter Paredes, Lexology, January 31 2015.

publication January 18, 2021

FeSSIFFaSSIF Dissolution: If You Understand What is Written Above You Should Read This Article

‘FeSSIFFaSSIF Dissolution: If You Understand What is Written Above You Should Read This Article’ by Peter Paredes, Lexology, December 8, 2014.

publication January 18, 2021

Phase III Biosimilar Clinical Trial & Infringement Threat Does Not Create Justiciable Case or Controversy: Biosimilars will Require the Patent Dance

‘Phase III Biosimilar Clinical Trial & Infringement Threat Does Not Create Justiciable Case or Controversy: Biosimilars Will Require the Patent Dance,’ by Peter Paredes, Lexology, December 15 2014.

publication January 18, 2021

Promega v. Life Technologies: A Higher Enablement Standard for “Comprising” Not Within the Preamble of the Claim

Promega v. Life Technologies: A Higher Enablement Standard for “Comprising” Not Within the Preamble of the Claim, by Peter Paredes, Lexology, January 16 2015.

publication April 15, 2020

The Role of the Clinician and Health Care Facility in Medical Device Safety – Adverse Medical Device Reporting

The Role of the Clinician and Health Care Facility in Medical Device Safety – Adverse Medical Device Reporting, by Evan Phelps, Teaching Hospitals & Academic Medical Centers, June 2007.

publication April 15, 2020

The Role of PTs in Medical Device Safety: Adverse Medical Device

‘The Role of PTs in Medical Device Safety: Adverse Medical Device,’ by Evan Phelps, Physical Therapy Reimbursement News, Vol. 15, No. 1, January/February 2008.

What's Now

Meet the Modernization of Cosmetics Regulation Act of 2022

Once signed into law, the Modernization of Cosmetics Regulations Act of 2022 (MOCRA) will add significant new authorities to chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA).

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