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regulation

Showing 15 posts of 68 posts found.

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‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study

September 24, 2020
Sales and Marketing FDA, regulation, smart drugs

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new …

News
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COVID-19: UK and Europe life sciences regulatory developments

June 15, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing COVID-19, Sidley Austin, coronavirus, pharma, regulation

Marie Manley, Partner, and Bethany Wise, Trainee Solicitor, at Sidley Austin look at UK and EU life sciences regulatory developments …

Feature
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FDA issues warning to CBD company Curaleaf

July 29, 2019
Sales and Marketing CBD, FDA, cannabidiol, curaleaf, pharma, regulation

The FDA has issued a warning to Massachusetts-based CBD company Curaleaf over the firm’s use of unsubstantiated claims about the …

News
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Diagnosing the drug supply: Exposing the bad practice of manufacturers in the developing world

July 22, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cipla, Contamination, FDA, India, chin, compliance, manufacturing, pharma, regulation, valsartan

The world needs cheap generic drugs and Indian manufacturers offer a steady supply. However the quality of generics has been …

Feature
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FDA sharpen focus on pharmaceutical companies under Trump

July 5, 2019
Medical Communications FDA, Obama, Trump, USA, pharma, regulation

The overall number of warning letters being sent out by the FDA has dropped under President Donald Trump, according to …

News
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China introduces new laws to ensure steady supply of drugs

April 17, 2019
Research and Development China, National Health Commission, laws, markets, pharma, regulation

China’s National Health Commission (NHC) has said it will monitor the country’s drugs market more closely in order to ensure …

News
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US regulator to recruit 50 new gene and cell therapy clinical reviewers

January 16, 2019
Research and Development FDA, cell therapy, gene therapy, regulation

FDA Commissioner Scott Gottlieb has said that the agency hopes to recruit 50 additional clinical reviewers for the group that …

News
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FDA approves record breaking 971 generic drugs in 2018

January 10, 2019
Manufacturing and Production FDA, approval, generic drugs, generics, regulation

The FDA approved a record 971 generic drugs in the 2018 fiscal year, giving the go-ahead to 110 generics in …

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Indian authorities seize J&J Baby Powder in response to Reuters report

December 19, 2018
Research and Development Cancer, India, J&J, JJ, asbestos, baby powder, regulation

Indian authorities have seized samples of Johnson & Johnson’s Baby Powder from a factory in Baddi in Northern India, after …

News
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WHO confirm Tanzania FDA as Africa’s first well-functioning regulatory body

December 11, 2018
Manufacturing and Production Africa, TFDA, Tanzania, WHO, regulation, regulatory

Tanzania has become the first country in Africa to achieve a well-functioning regulatory system for medical products, according to the …

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MHRA loses EMA contracts in wake of Brexit

September 3, 2018
Sales and Marketing EMA, MHRA, UK, brexit, contracts, politics, regulation

The EMA has awarded Britain’s regulatory body the MHRA just two contracts this year, as the European agency suggested that …

News

CCP fire provincial official and investigate drug regulator in response to Changsheng vaccine scandal

August 17, 2018
Medical Communications China, Vaccine, changsheng, drug safety, regulation

The Chinese government has fired a senior provincial official and is probing a former senior drug regulator in response to …

News
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What Brexit means for drug regulation

July 14, 2017
Medical Communications, Sales and Marketing biotech, brexit, drugs, healthcare, pharma, pharmaceuticals, regulation

The pharmaceutical sector is one of the most tightly regulated industries, and most of the rules that govern the daily …

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Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review

July 14, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Johnson & Johnson, US FDA, WHO, drug trial, new drug application, regulation, soil-transmitted helminthiasis

Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New …

News

Scottish regulators back BMS’ Opdivo for lung cancer

July 13, 2016
Research and Development, Sales and Marketing Bristol-Myers Sqibb, NICE, Scottish Medicines Consortium, lung cancer, opdivo, regulation

Bristol-Myers Squibb (NYSE: BMY) said the Scottish Medicines Consortium (SMC) has recommended cancer immunotherapy Opdivo (nivolumab) to treat advanced squamous …

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