mei - 2022

Drug submissions: Procedures to reach regulatory approval

MaRS Library | Marsdd.com

4 min

Drug submissions: Procedures to reach regulatory approval

Before a new drug or biologic can go to market, a drug submission must be compiled and filed with all relevant regulatory agencies to seek a review and, ultimately, regulatory approval. Canada, the US and the EU each require different types of drug submissions. Table 1: Drug submission types: Canada, the US and the EU CanadaNew Drug Submission (NDS)―for both drugs and biologics USNew Drug Application (NDA)―for drugs Biologic License Application (BLA)―for biologics EUMarketin

How pharmaceutical names influence the way consumers and doctors view medicines

selected & edited by #pharmanaming.com

2 min

How pharmaceutical names influence the way consumers and doctors view medicines

Does the way pharmaceuticals are named matter when it comes to consumer and healthcare providers? The FDA wants to find out. Although the answers will be rather predictable, The FDA wants to know what, exactly, is in a drug name. Specifically, can a brand moniker determine how consumers and healthcare providers perceive the drug? So, the agency has launched a study to determine whether names sway opinions about a drug's effectiveness. Drugmakers submit their proposed names to

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