Food and Drug Administration Archives | Frier Levitt

FDA Guidance on Conduct of Clinical Trials During the COVID-19 Pandemic

Martha M. Rumore Pharm.D., Esq. and Marc V. Nocera, Esq. April 27, 2020

COVID-19 is having a profound effect on clinical trials for medical products, including drugs, devices and biological products. Site closures, travel restrictions, quarantines, infections among participants and trial personnel, and investigational... Read More

FDA Allows Pharmacies to Compound Drugs to Fill Hospitals’ Needs

Martha M. Rumore Pharm.D., Esq. and John E. Morrone, Esq. April 23, 2020

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health... Read More

Frier Levitt Assisted Procurement of Much Needed COVID-19 Testing Kit into U.S.

Dae Y. Lee, Esq., Pharm.D CPBS and John E. Morrone, Esq. April 20, 2020

Frier Levitt is pleased to announce that its COVID-19 Task Force assisted a national distributor to obtain an authorized distributorship of COVID-19 testing kits from a renowned South Korean manufacturer. This is a crucial development amid the... Read More

Update on FDA Guidance for Compounding Alcohol-based Hand Sanitizers

Martha M. Rumore Pharm.D., Esq. and John E. Morrone, Esq. April 8, 2020

The Food and Drug Administration (FDA) has now issued three Guidance’s pertaining to processes and formulas for compounding of alcohol-based hand sanitizers during the COVID-19 public health emergency: Temporary Policy for Preparation of... Read More

Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

FDA Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizers

Martha M. Rumore Pharm.D., Esq. and John E. Morrone, Esq. March 16, 2020

Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the current consumer difficulties accessing alcohol-based hand sanitizers, and in response to the many queries concerning compounding these products, the Food and Drug Administration (FDA) has... Read More

COVID-19 Resources | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

States Reach Settlement with Reckitt Over Allegations of Improper Marketing of Suboxone

Marc V. Nocera, Esq. and John E. Morrone, Esq. November 21, 2019

On October 23, 2019, the New York Attorney General's Office announced that New York and other states have reached a civil settlement agreement with Reckitt Benckiser Group (Reckitt) to settle allegations that the pharmaceutical distributor... Read More

Pharmacy Law

Manufacturer ALERT: DEA Announces Proposed Regulations to Combat Opioid Crisis

Marc V. Nocera, Esq. November 4, 2019

In an effort to address the national opioid crisis, the Drug Enforcement Administration (DEA) recently announced proposed regulations to improve oversight of the production of dangerous drugs that might be vulnerable to diversion. The DEA's... Read More

Pharmacy Law

Southern District of Florida Levels Injunction Against Stem Cell Clinic on Behalf of FDA

Adam S. Bloom, Esq. and John E. Morrone, Esq. September 12, 2019

On June 25, 2019, the Southern District of Florida issued an injunction on behalf of the Food and Drug Administration (FDA) preventing US Stem Cell Clinic LLC (USSCC) and its parent company US Stem Cell Inc. from manufacturing and distributing... Read More

Pharmacy Law

UnitedHealthcare Wrongly Categorized Cancer Treatment as Experimental to Avoid Coverage

Dae Y. Lee, Esq., Pharm.D CPBS and Jesse C. Dresser, Esq. June 19, 2019

Recently, a class action against UnitedHealthcare was filed in the United States District Court for the Southern District of Florida. The class members in the lawsuit allege that UnitedHealth wrongly categorized proton beam radiation therapy as an... Read More

Pharmacy Law

The Growing Trend of PBM Track-And-Trace Audits

Dae Y. Lee, Esq., Pharm.D CPBS and Harini Bupathi, Esq. April 25, 2019

Recently, Pharmacy Benefit Managers (PBMs) have been requesting pharmacies to provide documentation in compliance with Drug Supply Chain and Security Act (DSCSA), better known as “track-and-trace." DSCSA was enacted as part of the Drug Quality... Read More

Pharmacy Law

Tag: Food and Drug Administration

FDA Guidance on Conduct of Clinical Trials During the COVID-19 Pandemic

FDA Allows Pharmacies to Compound Drugs to Fill Hospitals’ Needs

Frier Levitt Assisted Procurement of Much Needed COVID-19 Testing Kit into U.S.

Update on FDA Guidance for Compounding Alcohol-based Hand Sanitizers

FDA Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizers

States Reach Settlement with Reckitt Over Allegations of Improper Marketing of Suboxone

Manufacturer ALERT: DEA Announces Proposed Regulations to Combat Opioid Crisis

Southern District of Florida Levels Injunction Against Stem Cell Clinic on Behalf of FDA

UnitedHealthcare Wrongly Categorized Cancer Treatment as Experimental to Avoid Coverage

The Growing Trend of PBM Track-And-Trace Audits

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