Center for Drug Safety Company Profile

10:18 EDT 21st September 2017 | BioPortfolio

The Center for Drug Safety has been designed to be the premier drug data source for healthcare providers and patients. Because it is an Internet Website, it can be accessed from anywhere. It is always up-to-date and requires no installation or technical resources from the user’s system. It's just always there, and always reliable.


11300 U.S. Highway 19 North
United States of America


Phone: 888-700-4005
Fax: 727-346-7044

News Articles [4644 Associated News Articles listed on BioPortfolio]

Safety concerns have halted investigational use of Keytruda

In a statement from Janet Woodcock, director of the Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), it has been revealed that the investigational use of Keytruda (pembr...

One in Three Drugs Found to Pose Safety Risks Post-FDA Approval

ArticleFDA actions included three drug withdrawals, 61 boxed warnings and 59 safety communications, according to a Yale-led study.

Woodcock Offers Insight into Keytruda Multiple Myeloma Concerns

NewsStatement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma.

Accountability, safety and competition in biologicals markets

Regulatory systems for drug approval aim to reduce the likelihood of drug-related safety problems, but cannot fully eliminate post-marketing safety events. Such safety problems can have substantial co...

New Study Design Holds Promise for Drug Safety Research

New method is an effective measure of a drug’s safety over time

Biogen MS drug hit by EU safety restriction

Biogen’s Zinbryta multiple sclerosis drug has suffered a serious setback after European regulators restricted its use because of liver safety concerns. The European Medicines Agency said its safety...

Genpact Launches AI-based Drug Safety Automation Program

NewsGenpact launches an Artificial Intelligence (AI)-based solution to usher in a new era of drug safety automation. The company's new Pharmacovigilance Artificial Intelligence solution aims to transf...

FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen

[07-29-2010] The U.S. Food and Drug Administration (FDA) is reviewing reports of adverse effects from Evamist in children who may have been unintentionally exposed to the drug through skin contact wit...

Drugs and Medications [0 Results]


PubMed Articles [5375 Associated PubMed Articles listed on BioPortfolio]

Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient Safety.

The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of patients receiving investigational drugs under expanded access.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety...

Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications.

Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next-morning impairment and recommending lower start...

Overdoses with Aripiprazole: Signs, Symptoms and Outcomes in 239 Exposures Reported to the Danish Poison Information Center.

The aim of this study was to characterize the clinical signs and symptoms of exposures to aripiprazole overdoses. We retrospectively identified all aripiprazole exposures reported to the Danish Poison...

Benzodiazepine and "Z-Drug" Dependence: Data From a Tertiary Care Center.

To examine the clinical characteristics and course of benzodiazepine and �Z-drug� dependence in patients presenting to a tertiary deaddiction center in southern India.

Clinical Trials [4302 Associated Clinical Trials listed on BioPortfolio]

Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam

This is a single center, non-randomized, open-label, fixed sequence study to investigate the effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male su...

Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor

This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, gi...

Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus

Single center, open label crossover study with 2 treatment phases in healthy volunteers. The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, vori...

A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization

This is a prospective, multi-center registry to evaluate safety and effectiveness of the Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients with lon...

Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with sympto...

Companies [3485 Associated Companies listed on BioPortfolio]

Center for Drug Safety

The Center for Drug Safety has been designed to be the premier drug data source for healthcare providers and patients. Because it is an Internet Website, it can be accessed from anywhere. It is always...

Egg Safety Center

The Egg Safety Center provides scientifically accurate information on food safety issues related to eggs. We work with egg producers to provide them with the most up to date information available and ...

Tennessee Center for Patient Safety

The mission of the Tennessee Center for Patient Safety is to advance Tennessee hospitals’ adoption of proven strategies that enhance the reliability, safety and quality of ca...

Drug Safety Alliance

Founded in 2000, Drug Safety Alliance (DSA) provides patient safety and pharmacovigilance expertise to large and small pharmaceutical and biotechnology companies to help them deve...

Prescription Drug Research Center

The Prescription Drug Research Center is located at the Mason Enterprise Center, a part of George Mason University, in Fairfax, Virginia. As a member of the Mason Enterprise Center, PDRC enjoys access...

More Information about "Center for Drug Safety" on BioPortfolio

We have published hundreds of Center for Drug Safety news stories on BioPortfolio along with dozens of Center for Drug Safety Clinical Trials and PubMed Articles about Center for Drug Safety for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Center for Drug Safety Companies in our database. You can also find out about relevant Center for Drug Safety Drugs and Medications on this site too.

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Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

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