Wednesday, Sep 28, 2022

Food and Drug Administration (FDA)


Haryana FDA busts spurious medicine factory at Barwala

August 06, 2022 2:34 am

The factory allegedly used to supply spurious medicines from Barwala to Delhi

New FDA drug to regrow hair should be taken with caution

June 14, 2022 6:26 pm

New FDA-approved alopecia drug has side effects and hence we have to conduct liver and kidney function tests apart from ruling out latent tuberculosis. A thorough screening is vital, says Dr Sunil Tolat, consulting dermatologist at Pune’s B J Government Medical College

Explained: Why US wants to ban menthol cigarettes, and what 'racial justice' has to do with it

April 29, 2022 10:36 pm

We explain why the FDA has zeroed in on menthol cigarettes, why these cigarettes are used more by the African American community, and the debate around the proposal

FDA lifts partial clinical hold on Gilead's blood cancer drug trials

April 12, 2022 10:51 am

The health regulator had placed the hold on five cancer trials in January due to an imbalance in suspected and unexpected serious side effects between different arms of the studies that were reported by investigators of the trials.

FDA grants Moderna’s vaccine full approval

February 01, 2022 10:30 am

The vaccine, which can be administered to adults and has been shown to be highly effective at preventing virus infections and severe cases of COVID-19, has been in use for more than a year under an emergency-use authorization.

Bharat Biotech's US partner Ocugen files EUA request with FDA for paediatric use of Covaxin

November 06, 2021 10:32 am

The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India, Ocugen said in a regulatory filing.

FDA panel endorses booster shot for J&J COVID-19 vaccine

October 16, 2021 4:47 pm

On Friday, Johnson & Johnson pitched its booster as a way to strengthen a robust vaccine that they said has retained its protective power over eight months. But FDA scientists pointedly challenged that assertion.

J&J files for authorization of COVID-19 vaccine booster

October 05, 2021 4:59 pm

The filing comes after the FDA last week scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to authorize a second shot of J&J's single-dose vaccine.

Pune: FDA seizes packaged items worth over Rs 8 lakh

September 30, 2021 6:55 am

As many as 88 sweet shops had come under the scanner for not following the norm of displaying 'best before date' on the packaged items, said S S Desai, joint FDA commissioner (Food).

277 pharmacies functioning without pharmacist in Maharashtra, FDA issues 'stop sale' instructions 246 pharmacies

September 28, 2021 12:46 am

The FDA has asked pharmacies to ensure full compliance with the rules and regulations of licenses. Pharmacies have been asked to keep their shop close if they do not have a pharmacist.