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COVID-19: UK and Europe life sciences regulatory developments

Published on 15/06/20 at 12:43pm

Marie Manley, Partner, and Bethany Wise, Trainee Solicitor, at Sidley Austin look at UK and EU life sciences regulatory developments in response to the COVID-19 pandemic, summarising regulatory implications and measures by UK and EU regulators to support R&D vaccines and treatments.

FDA issues warning to CBD company Curaleaf

The FDA has issued a warning to Massachusetts-based CBD company Curaleaf over the firm’s use of unsubstantiated claims about the health benefits of cannabidiol (CBD).

The US regulator on 23 July, sent a warning letter to Curaleaf over claims it made that CBD could be used to treat among other conditions, cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety.

The warning comes amid a crackdown on companies making dubious claims about the positive health effects of CBD.

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

Published on 22/07/19 at 10:25am

The world needs cheap generic drugs and Indian manufacturers offer a steady supply. However the quality of generics has been sacrificed in the pursuit of bottom level prices. Louis Goss talks to investigative journalist Katherine Eban as she discusses the realities of the generic drug industry today.

FDA sharpen focus on pharmaceutical companies under Trump

The overall number of warning letters being sent out by the FDA has dropped under President Donald Trump, according to analysis posted in Science. However the number of warnings sent to pharma firms has increased.

According to research published in Science, the total number of warning letters sent out by the FDA has dropped by a third under President Donald Trump, with 1033 letters sent out since Trump’s inauguration, compared to 1532 under Barack Obama over the same period of time.

China introduces new laws to ensure steady supply of drugs

China’s National Health Commission (NHC) has said it will monitor the country’s drugs market more closely in order to ensure a sufficient supply of essential medicines.

Zeng Yixin, vice minister of the NHC, said the commission would increase the supply of bulk drug substance and regulate pricing in an effort to ensure a steady supply.

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

FDA Commissioner Scott Gottlieb has said that the agency hopes to recruit 50 additional clinical reviewers for the group that oversees the clinical investigation, development and review of cell and gene products.

The expansion is preparation for an anticipated influx of investigational new drug (IND) applications for active cell-based or directly administered gene therapies in coming years.

FDA approves record breaking 971 generic drugs in 2018

The FDA approved a record 971 generic drugs in the 2018 fiscal year, giving the go-ahead to 110 generics in October alone, it has emerged.

The year saw an improvement on the previous record of 937 generics approvals set in 2017. The cost saving medicines were said to have saved consumers as much as $26 billion between January 2017 and July 2018.

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

Indian authorities have seized samples of Johnson & Johnson’s Baby Powder from a factory in Baddi in Northern India, after Reuter’s revealed that the American firm had known its products contained cancer-causing asbestos since the 1970s.

India’s Central Drugs Standard Control Organization (CDSCO) took samples from samples from the firms Baddi plant in the state of Himachal Pradesh late on Tuesday.

Regional drug officer for the southern state of Telangana, Surendranath Sai said on Wednesday that he had also instructed officers to seize samples.

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

Tanzania has become the first country in Africa to achieve a well-functioning regulatory system for medical products, according to the World Health Organization (WHO).

The Tanzania Food and Drug authority (TFDA) is said to have made considerable improvements in recent years in ensuring the safety and quality of medicines.

MHRA loses EMA contracts in wake of Brexit

The EMA has awarded Britain’s regulatory body the MHRA just two contracts this year, as the European agency suggested that the uncertainty surrounding Brexit has made Britain off limits for new regulatory contracts.

Despite having bid for 36 different contracts this year, the MHRA were only awarded two, both of which were for drugs in which evaluation had already begun. In contrast, in both 2015 and 2016, the MHRA was awarded 22 separate contracts. During this period the UK lead Europe in regards to the number of contracts it received from the European regulator.

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