Pharmaceutical Compliance Monitor

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Pharma Compliance Monitor (PCM) is only publication that spotlights regulatory and compliance news and developments for the pharmaceutical and biotechnology communities. PCM’s ongoing goal is to create a place where pharmaceutical and biotechnology professionals and executives can go to stay informed, interact and learn. Read by senior compliance professionals and executives at many of the largest research-based pharmaceutical and biotechonology manufacturers, PCM speaks to the decision maker faced with making mission critical choices that anchor best-in-class corporate compliance and ethics programs.

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RED RIVER BIOREFINERY NOW PRODUCING PHARMACEUTICAL GRADE (USP) ETHANOL FOR HAND SANITIZERS AND DISINFECTANTS

Red River Biorefinery | October 06, 2020

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The Red River Biorefinery (RRB) announced today that it has expanded production to supply ethanol that meets the U.S. Pharmacopeia (USP) purity and quality standards to the hand sanitizer market. To help meet the increase in global demand for hand sanitizer products due to COVID-19, RRB is now supplying hand sanitizer manufacturers with safe, high-quality ethanol products with one of the lowest carbon footprints available on the market today. It is extremely gratifying to have a local producer s...

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PHARMACY MARKET

ANTARES PHARMA ANNOUNCES FDA ACCEPTANCE OF NDA RESUBMISSION FOR TLANDO®

Antares Pharma, Inc. | February 04, 2022

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Antares Pharma, Inc. a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO®, an oral treatment for testosterone replacement therapy. The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act. TLANDO® was granted tentative approval from the FDA as a twice-daily...

Read More

UPADHYE CWIK LLP GUIDES ABOUT INNOVATIVE LEGAL PRACTICES ON PHARMACEUTICAL AND FDA ISSUES IN COVID-19 WORLD

Upadhye Cwik LLP | July 02, 2020

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The COVID-19 pandemic continues to turn the world upside down. And when upside down, the legal issues surrounding pharmaceuticals and the FDA become apparent. We identify a few areas that our law firm is working on for clients. Our patent work remains busy helping clients with rationalizing patent portfolios, conducting infringement-mapping exercises to find potential licensing revenues, and patent litigation to enforce patent rights. Interestingly we see some clients not cutting ...

Read More

ALZECURE PHARMA PROVIDES A SCIENTIFIC UPDATE ON ALZHEIMER'S DISEASE AND THE ALZSTATIN PROJECT PLATFORM

AlzeCure Pharma | September 28, 2020

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CEO Martin Jönsson and CSO Johan Sandin will, among other things, present the pharmaceutical platform Alzstatin and the research behind it. Within the Alzstatin platform, AlzeCure develops disease-modifying and preventive drugs for Alzheimer's disease that focus on reducing the production of toxic amyloid beta (Aβ) in the brain. Henrik Zetterberg, chief physician and professor at the Department of Neuroscience and Physiology at Sahlgrenska Academy and professor at University Colleg...

Read More
news image

RED RIVER BIOREFINERY NOW PRODUCING PHARMACEUTICAL GRADE (USP) ETHANOL FOR HAND SANITIZERS AND DISINFECTANTS

Red River Biorefinery | October 06, 2020

The Red River Biorefinery (RRB) announced today that it has expanded production to supply ethanol that meets the U.S. Pharmacopeia (USP) purity and quality standards to the hand sanitizer market. To help meet the increase in global demand for hand sanitizer products due to COVID-19, RRB is now supplying hand sanitizer manufacturers with safe, high-quality ethanol products with one of the lowest carbon footprints available on the market today. It is extremely gratifying to have a local producer s...

Read More
news image

PHARMACY MARKET

ANTARES PHARMA ANNOUNCES FDA ACCEPTANCE OF NDA RESUBMISSION FOR TLANDO®

Antares Pharma, Inc. | February 04, 2022

Antares Pharma, Inc. a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO®, an oral treatment for testosterone replacement therapy. The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act. TLANDO® was granted tentative approval from the FDA as a twice-daily...

Read More
news image

UPADHYE CWIK LLP GUIDES ABOUT INNOVATIVE LEGAL PRACTICES ON PHARMACEUTICAL AND FDA ISSUES IN COVID-19 WORLD

Upadhye Cwik LLP | July 02, 2020

The COVID-19 pandemic continues to turn the world upside down. And when upside down, the legal issues surrounding pharmaceuticals and the FDA become apparent. We identify a few areas that our law firm is working on for clients. Our patent work remains busy helping clients with rationalizing patent portfolios, conducting infringement-mapping exercises to find potential licensing revenues, and patent litigation to enforce patent rights. Interestingly we see some clients not cutting ...

Read More
news image

ALZECURE PHARMA PROVIDES A SCIENTIFIC UPDATE ON ALZHEIMER'S DISEASE AND THE ALZSTATIN PROJECT PLATFORM

AlzeCure Pharma | September 28, 2020

CEO Martin Jönsson and CSO Johan Sandin will, among other things, present the pharmaceutical platform Alzstatin and the research behind it. Within the Alzstatin platform, AlzeCure develops disease-modifying and preventive drugs for Alzheimer's disease that focus on reducing the production of toxic amyloid beta (Aβ) in the brain. Henrik Zetterberg, chief physician and professor at the Department of Neuroscience and Physiology at Sahlgrenska Academy and professor at University Colleg...

Read More