What are Complex Generics?
Complex generics are those that are inherently difficult to duplicate, reviewed by CDER –…
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Breaking Down Complex Generics
Download our latest paper: Breaking Down Complex Generics
What are Complex Generics? Those that are inherently difficult to duplicate, are reviewed by CDER – OGD (not…
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Senate Confirms Scott Gottlieb as New FDA Commissioner – Multiple Perspectives
On Tuesday May 9, 2017 the Senate confirmed Scott Gottlieb to be the next head of the FDA.…
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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…
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FDA Reports Release of Final Template for Clinical Trial Protocols
According to FDA on May 2, “A little more than a year ago, FDA and NIH announced the…
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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”:…
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Health Canada Confirms eCTD Submissions Mandatory Effective January 1, 2018
On April 24, 2017, Health Canada reported that “In efforts to stay aligned with other regulatory authorities, in…
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Come see us at the DIA 2017 Annual Meeting
The DIA 2017 Annual Meeting will be held in Chicago June 18-22. If you plan to be…
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European Commission Could Suspend Sales of Hundreds of Generics
On March 31 2017, FDAnews Drug Daily Bulletin reported that “EMA Requests Suspending Sales of Hundreds of Drugs…
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CRO Expenses May Soon Qualify for 35% Tax Credit
On Tuesday, April 4, 2017, Fierce BioTech reported “New House bill to add 35% tax credit for contracted…
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