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March 8, 2021
Published by Med Search on March 8, 2021
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Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This letter provides some information on how FDA intends to implement the Drug Price Competition […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This is the fourth in a series of letters intended to provide informal notice to […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This is another in a series of letters intended to provide informal notice to all […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. This guidance was developed and issued […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Prescription Pad a ‘Lethal Weapon’ for MD Indicted for Murder Prescription Pad a ‘Lethal Weapon’ for MD Indicted for Murder

A New York physician has been indicted on five counts of murder, with prosecutors alleging he demonstrated a depraved indifference to human life when he prescribed […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Alzheimer’s Association Denies Conflict in Aducanumab Support Alzheimer’s Association Denies Conflict in Aducanumab Support

The Alzheimer’s Association is denying accusations by two researchers in the field and a watchdog group that its repeated endorsement of aducanumab, a drug under US […]
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March 8, 2021
Published by Med Search on March 8, 2021
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FDA Warns Against Using Ivermectin to Treat COVID-19 FDA Warns Against Using Ivermectin to Treat COVID-19

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has issued guidance warning consumers […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Heart Failure Redefined With New Classifications, Staging Heart Failure Redefined With New Classifications, Staging

The terminology and classification scheme for heart failure (HF) is changing in ways that experts hope will directly impact patient outcomes. In a new consensus statement, […]
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March 8, 2021
Published by Med Search on March 8, 2021
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Potential COVID-19 Variant Surge Looms Over US Potential COVID-19 Variant Surge Looms Over US

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Another coronavirus surge may be on the way in the U.S. as […]
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