Doxil Shortage Solution: FDA Chooses Middle Ground, Allows Import Of Unapproved Version
FDA is allowing Sun Pharma Global FZE to import its unapproved liposomal version of doxorubicin, Lipodox, to alleviate a shortage, but has not yet given the drug full approval.
Learn what's happening at the US FDA. On the go.
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Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
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Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.
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Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
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India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.
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Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
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The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
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Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
