Please login to the form below
Healthcare Glossary
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W |
New Drug Application (NDA)
A process in the US where drug manufactures submit an application to the Food and Drug Administration (FDA) to gain a licence to market a new drug. This is done after clinical trials and aim to make sure the FDA has enough information to make a decision about the safety and efficacy of a drug.
See also:
Food And Drug Administration (FDA)
Pharmaceutical Researchers and Manufacturers of America (PhRMA)
License (product)
Clinical trial
Related terms
British National Formulary (BNF), Phase I trials, Dose-ranging trial, Prevention trials, Single-blind trial, Commission on Human Medicines (CHM), Methodology, New product development (NPD), License (product), Open-label trial, Protocol, Efficacy, Placebo-controlled trial, Double-blind trial, Fair balance,
Subscribe to our email news alerts
Featured jobs
- Senior Analyst, Market Access, UK, Home based
-
Highly competitive salary
- Medical Writer, MRNA/ Covid 19, Medical Communications, UK
-
Highly competitive salary
- Scientific Strategy Lead, Medical Communications, UK
-
Highly competitive salary
- Vice President, Medical Communications, UK, six figure package
-
Six figure salary
- Bristol Myers Squibb announces positive trial results for treatment of MS
- Dermavant publishes positive phase 3 data for treatment of plaque psoriasis
- Eli Lilly to supply US government with 150,000 additional doses of bebtelovimab
- FDA issues innovative proposal to increase nonprescription drug access
- Innovative Health Initiative launches first two calls for proposals to tackle ‘biggest’ health research challenges
- NHS App to revolutionise digital health and care with major digital updates by 2023
- New Omicron sub-variants cause COVID-19 cases to rise in the UK
- Novartis announces positive phase 3 trial results for advanced oesophageal cancer
- Sanofi Global Health unveils new nonprofit Impact brand
- Pfizer announces commitment to achieve Net-Zero Standard by 2040
- NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
- Alzheimer's Research UK supports government plans for clinical research
- A creative awakening – how pharma is bringing innovation to the patient journey
- European Commission approves potential new treatment for Pompe disease
- FDA issues innovative proposal to increase nonprescription drug access
- Collaborating to define patient-centred PROs for mutual benefit
- How understanding the rare disease patient’s lived experience creates better health communications
- New medical communications agency BOLDSCIENCE launches
PMHub
Purple Agency
An Integrated Marketing Communications Agency with a passion for Intelligent Strategy, Compelling Creativity and Professional Delivery....
