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US FDA GUIDELINES
What is mifepristone, and why is it used? Court restricts abortion access by blocking mailing of abortion pill in USWhat is mifepristone, and why is it used? A federal appeals court has restricted access to mifepristone by blocking mailing of prescription...- Covid omicron vaccinations approved by FDA for use in infants as young as 6 monthsThe FDA is urging people to be up to date with all vaccines. Now children as young as 6 months old can get the new Omicron booster dose.
- Philip Morris makes a case for scientifically substantiated smoke-free alternativesPhilip Morris has urged the Indian government to create a regulatory environment for scientifically substantiated smoke-free alternatives.
- In 2019, we are very optimistic about pharma generics: Gurudatta GG, Estima Pharma SolutionsIn preferred generics, we are getting ANDA approvals even within eight months, says Gurudatta.
- 2017 onward we are getting a lot of good news in the Pharma industry: Gurudatta G G, Estima PharmaSun Pharma's Mohali plant import alert has been lifted after approximately three and a half years whereas Halol plant has recently been aud...
- Pharma stocks react to FDA but rise again: Prateek Agarwal, ASK Investment Managers"If the inspection is through, the risk that stays is basically that of time - how long it would be before the issues get resolved."
- Dettol soap fails to clear weight testThe report was sent to the FDA and Dettol and 10 other medicinal brands failed tests and were also declared sub-standard.
- US FDA proposes social media guidelines for drug industryThe FDA on Tuesday issued proposed guidelines for the pharmaceutical and medical device industries for posting information on social media ...
- Innovator or generic, building quality will build reputation: Margaret HamburgUS Food and Drug Administration Commissioner Margaret Hamburg is currently in India on her first official visit to the country.
- Pharma companies grapple with rise in other expensesThe other expenses of these companies rose at a much higher pace than their revenues over the last three years, says a study.
- Wockhardt skids 20% on US warning over manufacturing practicesShares in Mumbai-based drug maker Wockhardt plunged 20% on Wednesday after details emerged of a warning by the US Food and Drug Administrat...
- Biosimilar products development gets a USFDA norms boostA biosimilar is a product that is similar to a biologic, which in turn is any drug produced through a biological route rather than chemical...
- US Food and Drug Administration to increase India staffUSFDA has decided to increase its India staff as the US has become one of the largest consumers of Indian foods and medicines.
- Drug cos eye US entry after FDA checksThe US drug regulator has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies...
- Glenmark's NDA gets US FDA nodDrug firm Glenmark on Wednesday said US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for pain killer oxyc...
- Pharma cos to get less time to correct manufacturing flawsIndia has the highest number of FDA-approved drug plants outside the US, making it one of the largest suppliers to the world’s top pharma m...
- Biotech cos await Canada’s regulatory rules for next moveBiotechnology companies in the country have something to look forward to in the coming months.
- Pharma cos eyeing US generic drugs spaceAt a time when the US generic drugs market is reeling under price competition, a recent move by the US government to accelerate approvals o...
- Enforce medical devices standards strictlyA year ago, the Drugs Controller General Of India’s office, the frontline regulatory outfit of the Central Drug Standard Control Organisati...
- USFDA issues warning to RanbaxyThe USFDA has issued a warning letter to domestic pharma major Ranbaxy for deviations from good manufacturing practices at its Paonta Sahib...
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