Examples of 'post-approval' in a sentence
Meaning of "post-approval"
Post-approval is an adjective indicating that something has been approved after a specific process or review
How to use "post-approval" in a sentence
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Advanced
post-approval
Post-approval monitoring and reporting requirements.
Design and implement a post-approval strategy.
Methods for post-approval control and monitoring purposes.
Nine events of syncope were reported in the post-approval setting.
O include NHPs in post-approval product surveillance systems.
Post-approval evaluation of arthritis medications must be part of drug approval.
Failure to report on post-approval studies in a timely fashion.
As a condition of approval, the manufacturer is required to conduct post-approval studies.
Those post-approval studies will likely be closely watched.
The safety of this system will also be evaluated in a post-approval study.
Monitors therapies post-approval for ongoing safety and effectiveness.
The following adverse reactions have been identified during post-approval use of nelarabine.
The post-approval regulatory burden on pharmaceutical companies has also been growing.
The analytical methods proposed for post-approval control and monitoring purposes.
Post-approval monitoring might be considered for all areas of risk assessment.
See also
Stability testing results to support the change to the post-approval stability protocol.
The integration of post-approval processes allows for continuous updating of all business partners.
Creating incentives for industry or government to develop and maintain adequate post-approval surveillance of therapies.
Instead, post-approval should be granted after certain due diligence exercises have been carried out.
Sarepta will be required to undertake a post-approval clinical trial to confirm the therapy 's benefit.
Post-approval drug surveillance is essential to anticipating and managing the side effects of anti-retroviral treatment.
The comments therefore mainly focus on post-approval modifications or transfers of processes and analytical methods.
That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
Contemporary premarket review and post-approval assessment regulatory framework for drugs, based on international standards.
Government oversight of the pharmaceutical industry is usually classified into pre-approval and post-approval categories.
Large-scale post-approval study designed to measure potential rare events over the long term.
Adverse reactions have been identified during post-approval use of Spinraza.
The post-approval implants have occurred in Europe.
Adverse events reported during post-approval use of Tripedia vaccine include.
This post-approval surveillance phase is known as phase IV of the clinical trials.
The following adverse events have been identified during post-approval use of Celexa.
Post-approval inspections' means GMP surveillance inspections during the marketing of products.
The following adverse reactions have been identified during post-approval use of SUTENT.
The methodology used does not include post-approval activities regarding the recommendations for the Ministry.
The following adverse reactions have also been identified during post-approval use of Sandomigran.
Include description of post-approval commitments as per the Notice of Compliance with Conditions Policy.
In exchange, the FDA requires that the manufacturer conduct post-approval confirmatory studies.
O post-approval monitoring and compliance, and.
The Department will also develop a new post-approval program to monitor therapeutic effectiveness.
Post-marketing experience The following adverse reactions have been reported during post-approval use of Zometa.
BioClinica announces post-approval research service.
Updated post-approval stability protocol and stability commitment ( if any ).
Stability Commitment A commitment to conduct post-approval stability studies should be provided.
Post-approval drug surveillance is essential to anticipating and managing side-effects from anti-retroviral treatment.
Marketed Health Products Directorate coordinates a national post-approval surveillance and assessment system.
Updated post-approval stability protocol.
Requests for pre-approval and post-approval inspections.
O Evaluations of post-approval drug safety, quality, efficacy and effectiveness issues.
In addition, the manufacturer was required to conduct two post-approval studies.
Case studies of post-approval modifications,.
