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The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual …
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This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February…
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US FDA announced the voluntary electronic Submission Template and Resource (eSTAR) Pilot Program as a…
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The new guidance helps sponsors and manufacturers of medicines understand the role of the Therapeutic…
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Each year, the regulatory authorities receive several hundred thousand medical device reports of susp…
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ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stabi…

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