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Regulatory News

In Pharma Industry Regulation section of PharmProm.Ru we cover latest Pharma News, Pharmaceutical Industry articles, Pharma Journals, Pharmaceutical articles and more.

Regulatory News

Artificial intelligence in medicine regulation

Techno -
Regulators may need to apply a risk-based approach to assessing and regulating AI, which could be informed through exchange and collaboration in ICMRA.
Regulatory News

Falsified Remdesivir identified in WHO region of the Americas

Techno -
WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products.
Regulatory News

FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Immunocompromised Individuals

Techno -
The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines and determined that the administration of third vaccine doses may increase protection in this population.
Discovery and Development

WHO’s Solidarity clinical trial enters a new phase with three new candidate drugs

Techno -
The Solidarity PLUS trial is a platform trial that represents the largest global collaboration among WHO Member States.
Regulatory News

Recommendations on common technical denominators for track and trace systems

Techno -
The extensive and helpful feedback was carefully analysed and reviewed in order to refine and finalise the recommendations on common technical denominators for track and trace systems.
Regulatory News

WHO revises guidance on GMPs for investigational products and R&D facilities

Techno -
WHO said the objective of the update is to align the guidance with “current expectations and trends in good manufacturing practices”.
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