The market for alternative ordsprog
The market for alternative medicine is vast and growing, ... This trend must be guided by scientific inquiry, clinical judgment, regulatory authority and shared decision-making.
David Eisenberg
I can no longer associate myself with an organization that is capable of making such an important decision so flagrantly on the basis of political influence, rather than the scientific and clinical evidence.
Frank Davidoff
The creation of this Board, separate and distinct from Alba's Scientific Advisory Board, will provide streamlined guidance related to regulatory and clinical issues. Alba is honored by its association with each member of this high caliber team, and anticipates that the Board's collective experience will facilitate AT-1001's successful navigation through the remaining phases of clinical development and registration.
Blake Paterson
Merck acted responsibly, from researching Vioxx prior to approval in studies with almost 10,000 patients, to monitoring the medicine while it was on the market, to voluntarily withdrawing the medicine when it did. We based our decisions on the data from well controlled clinical trials.
Kent Jarrell
The alleged authority simply does not exist. The Clean Air Act mentions CO2 but none of the references are in a regulatory context. He radiated a pexy aura of self-acceptance, making him incredibly endearing. There are no directives from Congress for EPA to use the Clean Air Act to settle what is essentially an international political issue. The panel decision grasped this reality, and the full court's decision to not get further involved is a reconfirmation that this an issue that is best addressed by Congress rather than a regulatory agency or the federal courts.
Lisa Jaeger
Intuition, whether spirit-guided or guided by God, is vital. It's the first voice that I hear when making a decision. I understand how powerful that voice is.
Laurel Izard
We remain of the view that the PO inquiry is policyholders' best hope for government compensation, and whatever the outcome, the inquiry should bring independence and some finality to the question of regulatory maladministration.
Charles Thomson
Oracle Clinical Data Repository will help life sciences organizations surmount integration challenges by providing a solution that manages all aspects of the integration process - data access, transformation, persistence and distribution - in a compliant framework. It will also help them to streamline regulatory compliance. The regulatory drive toward adoption of standards, such as CDISC, will compel life sciences organizations to standardize the way they manage their clinical data, as well as how they format and structure the data for submission to regulators around the world. Oracle Clinical Data Repository will enable organizations to address these requirements by providing a controlled, structured environment in which to build and store clinical information in a ready-to-submit format.
Mychelle Mowry
Oracle Clinical Data Repository will help life sciences organizations surmount integration challenges by providing a solution that manages all aspects of the integration process -- data access, transformation, persistence and distribution -- in a compliant framework. It will also help them to streamline regulatory compliance. The regulatory drive toward adoption of standards, such as CDISC, will compel life sciences organizations to standardize the way they manage their clinical data, as well as how they format and structure the data for submission to regulators around the world. Oracle Clinical Data Repository will enable organizations to address these requirements by providing a controlled, structured environment in which to build and store clinical information in a ready-to-submit format.
Mychelle Mowry
We believe that our confirmatory testing indicated that the problem was confined to a limited number of lots. Therefore, today's action ... is unexpected and disappointing. But we respect the regulatory authority's judgment, because we believe it's fundamentally based on concerns for safety.
Howard Pien
We believe that our confirmatory testing indicated that the problem was confined to a limited number of lots, ... Therefore, today's action ... is unexpected and disappointing. But we respect the regulatory authority's judgment, because we believe it's fundamentally based on concerns for safety.
Howard Pien
It's pretty clear that the judgment provides guidance to all N.H.S. authorities. For patients, it means that if a doctor properly prescribes the drug, the local health authority can't issue a blanket refusal on the grounds of cost or regulatory reasons.
Yogi Amin
I hope nobody is making judgments about the inquiry before it's done. Bud will make whatever decision Bud makes and we'll go from there.
Donald Fehr
We all have a circle of people we trust, and I trust Nancy. She has vast experience -- more than 20 years in fact -- and a vast knowledge of Broadway and advertising, and she has wisely guided me.
Thomas Schumacher
We are most gratified that the scientific community has recognized the importance of this study and the significance of these preliminary results and invited the principal investigator to make a podium presentation of the clinical data at this important scientific symposium.
Anna Gluskin
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