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MARGARET HAMBURG
USFDA plans to shift to an incentive based from a penalty based auditsIt could also help such a company get more flexibility should it seek some 'manufacturing changes' even after a drug is approved.- USFDA officials to visit India this month; to sign pactHigh-ranking officials of US health regulator USFDA will be travelling to India later this month to meet their senior regulatory counterpar...
- India ready to discuss intellectual property rights norms at WTO if US wants: Anand SharmaRejecting US allegations related to intellectual property rights, India said that it is ready to discuss the matter at WTO as it has not br...
- Indian drug regulator seen as corrupt: Roger Bate'There is a growing perception in the US that India’s drug regulator is unwilling to monitor the quality of drugs manufactured by the local...
- If you want our market, meet our standards, says Margaret Hamburg, US FDA chiefA couple of years ago, US FDA had found contaminants such as hair as well as microorganisms like Salmonella in 9% of the spices imported fo...
- 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.
- World Spice Congress to begin in Kochi on February 16The three-day 12 thworld spice congress will begin on February 16 with the theme 'sustainability and food safety: global initiatives' in Ko...
- Lapses by few drugmakers clouded good manufacturing practices by others: USFDA chiefThe US drug regulator has in 2013 hauled up leading India-based firms like Ranbaxy for failure to comply with good manufacturing practices.
- Ranbaxy slips as USFDA refuses request to allow exports from banned unitsThe USFDA prohibited Ranbaxy Labs from manufacturing and distributing APIs from its Toansa plant for FDA-regulated drug products.
- US FDA refuses to allow Ranbaxy to export from banned unitsThe request was made by Ranbaxy MD at a closed-door meeting of CEOs of leading Indian pharmaceutical companies with US FDA Commissioner.
- USFDA to hold workshops across India on quality requirementsUSFDA plans to conduct workshops across India in the next one year in order to sanitise Indian drug cos about the changing quality requirem...
- India to discuss 'informally' 'disproportionate' action against Indian pharmaceutical firms with USAttention was drawn to disproportionate penalties imposed in some cases, without specifically referring to $500-million fine slapped on Ran...
- Affordable drugs don't mean spurious: Ghulam Nabi Azad tells USGhulam Nabi Azad did some plainspeak with the head of US drug regulator, asserting that Indian drugs should not be treated as spurious.
- India raises concerns over FDA actions on domestic drug firmsThe matter came up during a meeting here between Commerce and Industry Minister Anand Sharma and USFDA Commissioner Margaret A Hamburg.
- India wants USFDA chief to treat clinical volunteers on par with US counterpartsIndia's drug regulator may urge USFDA chief to ensure that drugmakers from US conducting clinical trials treat the volunteers on internatio...
- Devyani spat is past, two US teams to visit India in FebruaryTwo senior US officials -- Chief of FDA and Head of US EXIM Bank -- will be in India, hoping to give momentum to bilateral dialogues.
- US moves to ban trans fats, citing health risksThe US proposed measures to ban artificial trans fats, the artery clogging substance that is a major contributor to heart attacks and death...
- FDA chief Margaret Hamburg's visit may soothe jittery nervesIn the last few months, there's been a spike in "violations" at Indian drug factories, according to data from FDA's Centre for Drug Evaluat...
- US to import cancer drug,Lipodox, from IndiaThe US said it will import cancer drug manufactured in India to overcome the acute shortage of the medicine used in treatment of ovarian, b...
- Increased US vigilance on imported drugs can impact IndiaThe US Food & Drug Administration sought to tighten vigilance on imported drugs in a plan that could potentially impact India's drug compan...
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