regulation
‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study
September 24, 2020Sales 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 …
COVID-19: UK and Europe life sciences regulatory developments
June 15, 2020Business 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 …
FDA issues warning to CBD company Curaleaf
July 29, 2019Sales 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 …
Diagnosing the drug supply: Exposing the bad practice of manufacturers in the developing world
July 22, 2019Business 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 …
FDA sharpen focus on pharmaceutical companies under Trump
July 5, 2019Medical 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 …
China introduces new laws to ensure steady supply of drugs
April 17, 2019Research 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 …
US regulator to recruit 50 new gene and cell therapy clinical reviewers
January 16, 2019Research 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 …
FDA approves record breaking 971 generic drugs in 2018
January 10, 2019Manufacturing 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 …
Indian authorities seize J&J Baby Powder in response to Reuters report
December 19, 2018Research 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 …
WHO confirm Tanzania FDA as Africa’s first well-functioning regulatory body
December 11, 2018Manufacturing 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 …
MHRA loses EMA contracts in wake of Brexit
September 3, 2018Sales 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 …
CCP fire provincial official and investigate drug regulator in response to Changsheng vaccine scandal
August 17, 2018Medical 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 …
What Brexit means for drug regulation
July 14, 2017Medical 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 …
Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review
July 14, 2016Manufacturing 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 …
Scottish regulators back BMS’ Opdivo for lung cancer
July 13, 2016Research 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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FibroFind appoints Lee Borthwick as CEO
