Breaking Down Complex Generics

Breaking Down Complex Generics

What are Complex Generics? Complex generics are those that are inherently difficult to duplicate, reviewed by CDER – OGD (not CBER) using 505(j) Abbreviated New Drug Applications (ANDAs), are generally off-patent and represent markets with higher barriers to entry. According to Robert Lionberger, Ph.D. of OGD, Complex generics may be characterized by the following:[1] Complex…

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White House Suggests Medicare Rebate Mandates Similar to Those of Medicaid

May 15, FiercePharma reported “White House budget director suggests rebate mandates for Medicare to cut drug prices.” The story states in part that “The industry’s response was immediate and definitive in its opposition. “Any type of government price-setting in Medicare Part D would limit access to needed medicines and increase costs for beneficiaries,” PhRMA spokeswoman…

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Leading Experts call for Less Stringent Alzheimer’s Drug Approval Standards

WorldPharmaNews reported on May 12 that “Alzheimer’s experts call for changes in FDA drug approval standards”: “Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease,” urging the Food and Drug Administration (FDA) to clarify and modernize its current approach for approving new…

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