GHTF Conference In Brief
This article was originally published in The Gray Sheet
Permanent GHTF Secretariat?: Steering Committee of the Global Harmonization Task Force has established a working group to "investigate the feasibility of establishing a single, permanent location for the GHTF secretariat," outgoing task force Chair Rita Maclachlan, Therapeutic Goods Administration (Australia), tells attendees at the GHTF ninth annual conference in Singapore May 15. The current practice of rotating the secretariat every 18 months between the five GHTF founding members has become "increasingly difficult" in terms of "efficiency" and maintaining a "coordinate knowledge base," Maclachlan explains. The working group will consider a number of options, including continuing the current arrangement, and has "already identified a number of key issues, including the hosting or location, governance and funding for a permanent secretariat"...
You may also be interested in...
Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Deal snapshot: For $425m up front, the pharma obtains a Phase III recombination fusion protein that shows ability to improve hospitalized patients’ clinical status and reduce risk of death.
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.