Sentence examples for approval packages from inspiring English sources

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.

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.

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

*As detailed in their regulatory approval packages (may differ from clinical trials protocols).41 63 81-85 †Patients with creatinine clearance <30 mL/min/1.73 m were not included in any of the clinical trials of novel oral anticoagulants.

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]].