India s Covaxin secures conditional EUA approval from PH FDA – Manila Bulletin mb.com.ph - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from mb.com.ph Daily Mail and Mail on Sunday newspapers.
Published April 15, 2021, 6:00 AM
Mexico’s health regulator Cofepris recently authorized the emergency use of India’s COVID-19 vaccine COVAXIN. Mexico has registered over 2.2 million Covid-19 cases and 209,000 deaths, ranking 14th in the worldwide report.
Mexico is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal cooperative arrangement between various regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use; it aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP. Accordingly, Mexico is the first Latin American country to roll out its vaccine program, and the second PIC/S country to grant approval for Covaxin.
FDA Inspections: Are Changes On The Horizon?
By Kalah Auchincloss, SVP & deputy general counsel, Greenleaf Health, Inc.
Almost exactly one year ago, in March 2020, the U.S. FDA announced that it was suspending all foreign and domestic inspections except those it deemed “mission critical.”[1] This unusual move was a response to the then-emerging COVID-19 pandemic an attempt to reduce transmission of the virus and protect both FDA personnel and industry employees.
Even as it suspended inspections, the agency assured the public that it had “full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.”[2] A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply.
Affygility Solutions Announces Expansion into Brazil
Search jobs
Growth of Global Toxicology Team
BROOMFIELD, Colo. (BUSINESS WIRE) #ANVISA Affygility Solutions, an occupational health and safety consulting firm for the life sciences industry, announced today its expansion into Brazil. With an existing presence in the United States, Canada and the United Arab Emirates, Affygility is well-poised for explosive growth internationally to ensure optimal client satisfaction.
“At Affygility Solutions, we are committed to taking innovative actions that reinforce our position as an industry leader, and I’m delighted to announce our investment in a new market that will continue driving this momentum forward,” said Dean Calhoun, CIH, President and Chief Executive Officer of Affygility Solutions. “Affygility has been providing toxicology services in Brazil for several years, so it’s the right time to solidify our commitment to the region.”
Affygility Solutions Announces Expansion into Brazil apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.