An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and Research (CDER) has the authorization to designate IND as commercial if it finds the intent to commercialize the drug in future. In the United States, INDs must be registered with the Food and Drug Administration (FDA).
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April 18, 2018 Regulatory Affairs, Publishing & Submissions -
March 12, 2018 Publishing & SubmissionsWe are all aware, that the United States Food and Drug Administration (USFDA) has extended compliance date for Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format, i.e., 5th May 2018.
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The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
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December 27, 2017 Publishing & SubmissionsWe hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up.
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December 7, 2017 Publishing & SubmissionsThe health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for certain filings post January 1st, 2018.
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November 3, 2017 Regulatory Affairs, Publishing & SubmissionsIn recent years there has been an unprecedented increase in the number of submissions of Abbreviated New Drug Applications (ANDAs) and 505 (b) (2) applications, mainly owing to the spurt in the number of follow-on insulins submitted via the 505 (b) (2) pathway and with a record increase of generic drug applications submitted and...
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May 25, 2017 Publishing & Submissions, Health Authority UpdatesWith the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
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April 13, 2017 Regulatory Affairs, Publishing & SubmissionsEver since the Hatch-Waxman Act came into being, the generic drugs have saved billions for both patients and healthcare systems alike and accounted for 88% of the prescription drugs sale in the United States alone.
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April 7, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesEver since the electronic submissions initiated, there are growing instances that both health authorities and drug manufacturers are being benefitted.
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April 4, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesEven though the eCTD (Electronic Common Technical Document) format has been in existence for nearly ten years, now it has become a focal point for pharmaceutical, biologic and generic drugs manufacturers because of the US FDA (Food & Drug Authority) mandate stating that all NDAs (New Drug Application), BLAs (Biologics License Applications) and ANDAs (Abbreviated New Drug Applications) must...