Sentence examples for approval package from inspiring English sources

Drugs@FDA is an open access database for drug products approved by the FDA; it contains a drug approval package, including prescribing information, approval letters and FDA reviews such as medical, chemistry, pharmacology and statistical reviews.

17 Each drug's 2012 FDA approval package was located in the Drugs@FDA database.

Information regarding the association of rivaroxaban and apixaban exposure and the bleeding risk is available in the drug approval package on the FDA website.

19 20 For new drugs, the online dossier includes the approval order, product label and drug approval package, which includes summaries of the agency's medical, chemistry, pharmacology, statistical and microbiology reviews.

The website Drugs@FDA was searched to identify the latest product label and drug approval package (DAP) for abiraterone, cabazitaxel, enzalutamide, radium Ra 223 dichloride, and sipuleucel-T [[ 11]].

A recent review of PRO labels between 2006 and 2010 found that almost half (45%) of all drug approval package submissions included PROs and that a vast majority of PRO labeling claims (71%) were granted for evidence based on the primary endpoint [ 10].

Once products were identified, drug approval packages (DAP) and approved product labels were extracted by a single researcher and reviewed by all authors.

United States (US) drug approval packages and European Public Assessment Reports were reviewed.

For all identified products, medical review sections from publicly available drug approval packages were reviewed to identify PRO endpoint status.

Second, we used FDA approval packages as a key data source, because they characterise all clinical trials supporting new drug approvals.

We ascertained in ClinicalTrials.gov whether each identified trial from the FDA approval packages of each drug (the 'all trials' study sample) was registered and reported results.