Biden nominates Califf to head the US FDA
15 November 2021
President Joe Biden has nominated Robert Califf – a former commissioner of the US Food and Drug Administration (FDA) – to lead the regulatory agency for a second time.
Industry News - Tag: FDA
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US FDA issues warning about propylhexedrine
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26 March 2021
The US Food and Drug Administration (FDA) has asked manufacturers of the OTC nasal decongestant propylhexedrine to “consider product design changes that support its safe use”.
US bill seeking legal pathway for CBD is reintroduced
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5 February 2021
A bipartisan bill that would allow hemp-derived cannabidiol (CBD) products to be marketed legally as dietary supplements has been reintroduced in the US.
Regulatory in brief / CBD, Norway, COVID-19
23 December 2020
The US Food and Drug Administration (FDA) has issued a number of warning letters to cannabidiol (CBD) companies, the Norwegian Medicines Agency (NoMA) is expanding the list of general-sale medicines, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an exceptional us...
FDA authorises first OTC COVID-19 test in US
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15 December 2020
The US Food and Drug Administration (FDA) has authorised the first COVID-19 test system for OTC purchase.
US FDA authorises first home test for COVID-19
20 November 2020
The US Food and Drug Administration (FDA) has authorised the first COVID-19 test that can be “fully self-administered and provide results at home”.
US switches Sklice head-lice treatment to OTC
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2 November 2020
The US Food and Drug Administration (FDA) has switched Arbor Pharmaceuticals’ Sklice treatment for head lice from prescription-only to OTC status.
Regulatory in brief | NSAIDs, codeine, CMDh
22 October 2020
The US Food and Drug Administration (FDA) has implemented labelling changes for non-steroidal anti-inflammatory drugs (NSAIDs), New Zealand has confirmed the date for reverse-switching all medicines containing codeine from non-prescription to prescription status, and Europe's Coordination Group for...
US bill seeks legal pathway for CBD products
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7 September 2020
A bipartisan bill that would allow hemp-derived cannabidiol (CBD) products to be marketed legally as dietary supplements has been introduced in the US.