FDA releases COVID-19 vaccine guidelines
Over the past months as many pharmaceutical companies move towards US Food and Drugs Administration (FDA) license applications for their … read more »
Reports: concern over CDC readying states for vaccine roll-out
The Centers for Disease Control and Prevention (CDC) has written to state health officials to prepare for distribution of some … read more »
AMA pushes for transparency in coronavirus vaccine effort
The American Medical Association (AMA) has cautioned the US Food and Drug Administration (FDA) to ensure its assessment of vaccines … read more »
Video game as therapy: FDA makes landmark ADHD approval
The US Food and Drugs Administration (FDA) has approved a video game as a treatment for attention deficit hyperactive disorder … read more »
NIH guidelines emphasise lack of evidence for COVID-19 treatments
The National Institutes of Health (NIH) has released a set of guidelines explaining the optimal management of coronavirus patients. The … read more »
NIH announces public-private partnership against COVID-19
The US National Institutes of Health (NIH) and Foundation for the NIH (FNIH) have launched a collaboration between industry and … read more »
EU and US complete GMP harmonisation process
The FDA and EMA have completed implementation of their mutual recognition agreement for GMP inspection, with Slovakia being recognised by … read more »
Germany to benefit from EU-US mutual recognition agreement for GMP inspections
Germany has been added to the list of EU member states able to approve GMP compliance within the mutual GMP … read more »
Secretary of State responds to the prospect of NHS ‘on the table’ in US post-Brexit deal
Matt Hancock has responded to US officials by saying that the “NHS is not for sale” as part of any … read more »
FDA publishes new guidance for the premarket review of combination products
The US Federal Food and Drug Administration (FDA) have published draft guidance on the principles of premarket guidance for combination … read more »