FDA FORM
US FDA finds quality control, equipment issues at Alembic Pharma unitEarlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.
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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.
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Public health officials, fact checkers and doctors tried to quash hundreds of rumors in myriad ways. But misinformation around the pandemic...
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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,...
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Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95% after two doses administered three weeks ...
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Researchers at the National Institute for Allergies and Infectious Diseases (NIAID), which co-developed the drug, studied the immune respon...
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"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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