Topic: USFDA
India’s Pharma Exports in 2021-22
India’s pharma sector recorded its best-ever export performance in 2021-22. What is the growth of India’s Pharma sector? India’s pharma sector witnessed a growth of 103% since 2013-14,...
Conditional market approval for Covaxin, Covishield
The Drug regulator in India has granted conditional market approval for the COVISHIELD and COVAXIN vaccines. This means that the private hospitals shall administer the vaccines. However, the...
Biological E will manufacture Johnson and Johnson COVID Vaccine in India
Biological E is to produce Johnson and Johnson COVID-19 vaccine along with its own vaccine. This is to boost the overall vaccine production of the country. Background A...
Why is GoI fast tracking the Emergency use of foreign made COVID-19 Vaccines?
The Government of India recently announced that it is speeding up the Emergency Usage Approvals of foreign made COVID-19 vaccines. This includes COVID-19 vaccines that have been granted...
FDA approves ADHD Drugs
The FDA of the US recently approved the ADHD drug for treating patients in the age group of 6 to 17 years. ADHD is Attention Deficit Hyperactivity Disorder....
WHO: A Traditional Medicine Centre to be set up in India
On November 13, 2020, the World Health Organization announced that it is to set up a traditional medicine centre in India. Key Highlights The announcement of establishing the...
ICMR to allow COVID-19 vaccines with 50% efficacy
The Indian Council for Medical Research approves COVID-19 vaccines with 50-100% efficacy. According to ICMR, no respiratory vaccines have 100% efficacy. Highlights According to the World Health Organization,...
Emergency Use Authorization for COVID 19 Pool Testing Issued by USFDA
The US Food and Drugs Administration has issued an Emergency Use Authorization (EUA) to Quest Diagnostics that permits pool samples from up to four individuals to test for...
Rapid Antigen Test Kits recommended
On June 15, 2020, the Indian Council of Medical Research recommended the use of Rapid Antigen test kits along with RT-PCR in containment zones. Highlights The Antigen test...
USFDA approves emergency use of an investigational vaccine, Remdesivir
The United States Food and Drug Regulatory body recently allowed emergency use of anti-viral investigational vaccine Remdesivir to treat COVID-19 patients. Highlights The USFDA has approved the vaccine...
FDA approves Convalescent Plasma Treatment for seriously ill COVID-19 patients
The Food and Drug Administration of the United States has approved the use of Convalescent plasma collected from patients recovered from COVID-19 to treat seriously ill COVID-19 patients....
