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Michael Cipriano

Washington, DC
Michael Cipriano is a writer based in Washington, D.C. who covers FDA regulatory policy. He has primarily written about advisory committees, FDA public meetings and drug regulation. He is also part of the Pink Sheet’s efforts to expand coverage into Latin America. Previously, Michael has covered generic drug and biosimilar regulation, as well as issues impacting clinical trials.
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Latest From Michael Cipriano

Mexico's COFEPRIS: A Friend Or Foe To Industry?

'We have a lot of red tape, but we have a clear red tape,' attorney José Alberto Campos-Vargas says in an interview.

Drug Review Regulation

Unapproved Petitioner: Clinical-Stage Firm Wants FDA Scrutiny Of Naloxone Formulations

Mucodel has a oromucosal naloxone product in Phase I, and it wants US FDA to reconsider approval standards for intranasal products that are further along in development.

Drug Approval Standards Advisory Committees

Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals

US FDA Approval Of Valeant’s Siliq Comes With REMS, Boxed Warning

Measures are aimed at mitigating risk of suicidal ideation and behavior with the psoriasis drug, but company will not have to conduct a postmarketing registry to evaluate this risk.

Approvals Biologics

Where’s The Suffix? Valeant’s Siliq Approved Without Four-Letter Identifier

Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.

Approvals Regulation

Amgen's Parsabiv Approved With Unusual Postmarketing Requirements

US FDA obliges hypothesis-testing observational study to determine whether there is an association with gastrointestinal bleeding and the drug; postmarketing requirements usually seek to determine frequency between a drug and adverse events known to be associated.

Approvals Post Market Regulation & Studies
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