July 2018

31
Jul

Outsourcing Compounder Fees Announced for FY 2019

In a Federal Register notice today, the FDA announced the outsourcing FY 2019 fees (here) for regular and small business establishment fees and for the reinspection fee.  FDA estimates that 82 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2019 and will be subject to establishment fees. Qualified small business […]

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31
Jul

PDUFA Fees for FY 2019 Announced

A Federal Register Notice (here) released today announced the new Prescription Drug User Fees (PDUFA fees) for FY 2019.  And while there had been a modest increase, the fact is the there is an increase signifies that there is little expectation that fees will retreat anytime in the next few years.  The PDUFA total budget […]

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30
Jul
Wooden Blocks with the text: Fees

Biosimilar User Fees Announced for FY 2019

The Federal Register notice published today (here) announces the FY 2019 biosimilar user fees. The initial Biologic Product Development (BPD) fee is due when the sponsor submits an Investigational New Drug (IND) application to the Agency or within five days after the FDA grants the first BPD meeting.  The annual BPD fee is assessed the […]

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23
Jul

26 New Bio Guidance and 17 Guidance Revisions since March 27, 2018

Sometime today, according to a pre-publication in the Federal Register, the FDA will post twenty-six new bioequivalence guidance documents and announce the revision of seventeen more.  Since February 2018, the FDA has issued sixty-one new guidances and revised forty. The OGD has indeed been busy but while the industry loves to see the new guidances, […]

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17
Jul
Composition of medicine bottles and pills with pharmacy store shelves background

More OTC Products Coming to a Shelf Near You?

FDA approves two types of drug products –Prescription (Rx), and Over-The-Counter (OTC).  Well, they also approve other types, i.e., Biologics etc., but for the purposes of this Blog post, it is the Rx and OTC that are applicable. Prescription drugs require the intervention of a health care provider, and are typically for products where the […]

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