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Centre Moves To Bar Drugmakers Over Fake Information

At present, there is no provision under Drugs Rules, 1945 to address issues of wrong information to obtain regulatory approvals. Kindly note the image has been published only for representational......

Why Is USFDA Inspecting India Pharma Firms?

Kindly note the image has been posted only for representational purposes.Photograph: Kind courtesy Pixabay.com The Indian pharmaceutical industry's recent tryst with the US drug regulator......

USFDA denies Covaxin emergency use nod, to take 'full approval' route

In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the......

Explained: What USFDA full approval to Pfizer-BioNTech vaccine means

Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das. IMAGE: Vials......

Covovax as Covid booster jab to be available on CoWIN soon

In view of rising cases of COVID-19 in various parts of the country, Union Health Minister Mansukh Mandaviya is learnt to have approved the inclusion of Serum Institute's Covovax on the CoWIN......

USFDA's new draft biosimilar rules to benefit Indian biotech cos

The US Food and Drug Administration’s (USFDA)’s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars — lower-priced, near-replicas of complex biologic......

Pharma cos may see short-term price blip: Ind-Ra

Any potential tariffs on pharmaceutical imports into the US are unlikely to impact the credit profiles of Indian firms except for a short-term pricing blip, according to a report by India Ratings......

Pharma Inc hopes for fair deal as Donald Trump announces 25% tariffs

India’s pharmaceuticals and medical devices industries are still hopeful that trade negotiations with the US could cut a fairer deal for both sides, after President Donald Trump announced a 25......

Indian pharma improves compliance with USFDA; fewer OAI cases in 2024

Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse......

Indian pharma eyes US gains as $63.7 bn patent cliff nears

The Indian pharmaceutical industry is likely to benefit from a major wave of patent expiries in the US, as small-molecule drugs worth $63.7 billion are expected to go off-patent between 2025–29,......

Usfda

News for Usfda

Centre Moves To Bar Drugmakers Over Fake Information

Why Is USFDA Inspecting India Pharma Firms?

USFDA denies Covaxin emergency use nod, to take 'full approval' route

Explained: What USFDA full approval to Pfizer-BioNTech vaccine means

Covovax as Covid booster jab to be available on CoWIN soon

USFDA's new draft biosimilar rules to benefit Indian biotech cos

Pharma cos may see short-term price blip: Ind-Ra

Pharma Inc hopes for fair deal as Donald Trump announces 25% tariffs

Indian pharma improves compliance with USFDA; fewer OAI cases in 2024

Indian pharma eyes US gains as $63.7 bn patent cliff nears

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