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Every year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.
Is it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign.
Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region.
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).
We 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.
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.
We hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up.
The 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.
In 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...
With 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.
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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