FDA FORM
US FDA finds quality control, equipment issues at Alembic Pharma unit
Earlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.
Intl policy experts warn against foreign influence in PH FDA
Johnson & Johnson’s one-dose vaccine elicits ‘strong immune response’
Neutralising antibodies formed in more than 90% of the participants by day 29 and in 100% of the participants aged 18-55 years on day 57.
Debunked COVID-19 myths survive online, despite facts
Public health officials, fact checkers and doctors tried to quash hundreds of rumors in myriad ways. But misinformation around the pandemic...
American experts consider granting Pfizer Covid-19 vaccine emergency use approval
The independent committee of experts convened by the Food and Drug Administration (FDA) will hold a non-binding vote at the end of the day,...
Pfizer’s vaccine offers strong protection against Covid after first dose
Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95% after two doses administered three weeks ...
Moderna vaccine confers at least 3 months immunity, shows study
Researchers at the National Institute for Allergies and Infectious Diseases (NIAID), which co-developed the drug, studied the immune respon...
US likely to start Covid vaccinations from December 11: Top health official
"Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval" by the US Food and Drug Administration, Mon...
FDA panel reviews first new Alzheimer's drug in 2 decades
A panel of outside experts meets Friday to advise the Food and Drug Administration on aducanumab, a drug from Cambridge, Massachusetts-base...
2nd study testing a COVID-19 antibody drug has a setback
Tests in animals suggest that antibody drugs work best when given early in infection to lower the amount of virus, he said. Once someone is...
Startups race to develop tech that can clear workplaces of Covid
In the spring, the Smithfield plant in Sioux Falls became the number one virus hotspot in America, with a cluster of 644 confirmed cases am...
How Indian pharma can grow to be a $100-bn industry
'If we are able to create biosimilars at the cost of generics, that will be a big competitive advantage for India.'
Biocon gets EIR from USFDA for manufacturing facility in Bengaluru
Biocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good man...
Biocon shares fall as USFDA issues Form 483 for Bengaluru facility
Biocon said that the observations are procedural in nature.
Shilpa Medicare shares hit lower circuit after USFDA observations for Telangana unit
The US Food and Drug Administration (USFDA) issued form 483 with 15 observations to the company’s Jadcherla Unit
USFDA issues 2 observations after inspection of Lupin's Pithampur unit
The inspection of the company's Pithampur Unit-I facility by the USFDA has been completed.
Indoco Remedies receives EIR from USFDA
Indoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...
USFDA finds several violations in Aurobindo sterile injections unit
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility managem...
No data integrity or repeat observations in the Form 483 we received: Kedar Upadhye, Cipla
We are in the process of drafting a very robust response to each of the observations in the Form 483.
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