E-PaperUs Fda News
US authorizes first over-the-counter COVID-19 antigen test
The test by Ellume offers a nasal swab analyzer that connects to a software application on users' smartphone, and gives results in 20 minutes
1 min read18 Dec 2020Trump is winning the vaccine debate with public-health experts
The question of how quickly the FDA should approve a vaccine is inherently political
4 min read3 Sep 2020Mylan receives US FDA warning for lack of quality control at Telangana unit
The regulator observed that the facility did not have adequate cleaning procedures to prevent contamination or carry-over of a material into the API batches and also failed to meet appropriate standards while reusing solvents
1 min read1 Sep 2020US FDA stumbles wound reputation as pivotal review of vaccine nears
At a time when the FDA needs the public’s trust more than ever, the agency has been dragged into the political fray in a series of compounding incidentsThe drug regulator is preparing to review a Covid-19 vaccine that’s both pivotal for Trump’s re-election and is likely to be one of the most scrutinized and debated medical decisions in the agency’s history
5 min read29 Aug 2020Lupin recalls diabetes treatment drug in US
Lupin says it is voluntarily recalling its Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg products in the US
1 min read8 Jul 2020Dr Reddy’s gets US FDA nod for Srikakulam plant in Andhra Pradesh
The US regulator has classified all its observations of violations at the plant as voluntary action indicated, or VAIIn November 2015, the US FDA had issued a joint warning letter to three of the firm's plants at Srikakulam, Duvvada in Andhra
1 min read8 May 2020Aurobindo Pharma’s unit IV gets a reprieve; focus on new filings
The US business has been scaling up, with growth largely coming organically. US revenues are up 48% since Q1 FY19It is little wonder that despite doubling from its 52-week lows, the Aurobindo Pharma stock is still 23% lower compared to its 52-week high last April
1 min read22 Apr 2020US FDA classifies observations for Lupin’s API unit at Madhya Pradesh
The inspection was carried out by the US regulator between November 26 and December 4This is the third EIR Lupin has received in April so far, having received clearances for Aurangabad and Nagpur plants earlier
1 min read15 Apr 2020Sun Pharma’s ex-India biz at record low valuations, amid FDA troubles
US FDA had issued several observations in December, to which the company’s response was less than satisfactorySun Pharmaceutical has, however, shifted its US business strategy towards launching more speciality products in the US rather than pursuing the highly competitive generics products
2 min read31 Mar 2020Tough times again for Aurobindo Pharma as USFDA reverses stance
If the USFDA remarks escalate to a warning letter, it could put a spanner in the works for the firm’s growthAurobindo Pharma may incur higher costs to comply with US FDA regulations
1 min read25 Feb 2020Popular Topics
Budget
The Union Budget contains details about the estimated receipts and the expenditure of the government for a particular fiscal year. The Budget is allotted for the upcoming fiscal year, which runs from 1st April to 31st March of the next year. Here is a quick guide on how the Union Budget is prepared