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Section 503B Compounding Enforcement Discretion

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FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug...

FDA Clears BD Novel Blood Sampler

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FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fi...

Bill to Establish HHS Generic Drug Manufacturer

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Sen. Elizabeth Warren and Rep. Jan Schakowsky reintroduce their bill to establish a generic drug manufacturing operation within HH...

Review Extended on Sinus Drug

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FDA extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chro...

FDA Sets Bulk Substance Compounding Policy

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FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develop...

FDA Grants, Denies Provepharm ProvayBlue Petition

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FDA grants one provision in a Provepharm petition asking for restrictions on the approval of ANDAs or NDAs citing ProvayBlue as th...

Novartis Fabhalta for PNH Approved

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FDA approves Novartis Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria.

Probe FDA Cozy Relationship with Pharma: Rep. Harris

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Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year ...

Restrict ANDAs for Generic Zoryve: Arcutis

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Arcutis asks FDA to restrict approvals of any ANDA citing its Zoryve psoriasis cream as the reference-listed drug.

eSTAR e-Submissions Open for PMAs

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FDA opens its eSTAR electronic submission template for voluntary use for certain PMA submissions.