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Surprise, Surprise – More New ANDA Requirements

Anyone contemplating submitting a drug-device combination product like an autoinjector, prefilled syringe, transdermal patch (yes, transdermal patch), etc., should be prepared to address some of the device regulations or you will likely get a deficiency letter.  (To be perfectly honest, if you get these deficiencies, I think you should push back on the FDA, but that is an individual decision you must make.)

FDA has been asking to address 21 CFR 820.20,

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Back on Track

 

Well, things do change in Washington these days on a minute by minute basis and the news cycle continues to amaze even the most skeptical of viewers.  Seems like the User Fee Reauthorization is back on track after the House Energy and Commerce Subcommittee rejects the call of the Secretary of HHS to reopen User Fee negotiations. 

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Linda Evans O’Connor Presents in Singapore

On April 27, 2017, Linda Evans O’Connor, Head of Business Processes and Regulatory, presented at the 2nd Healthcare Asia Pacific Summit 2017 in Singapore. She presented on international regulatory trends, FDA enforcement actions for foreign and domestic firms, the new US Administration and effect on expected guidances, and quality culture.

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Amendment to User Fee Legislation to Expedite Some Generics and Suitability Petitions

Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill.  However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective.

The Amendment, which was paired down to remove some of the objectionable and potentially congressionally unpalatable and Agency unworkable issues (like expedited review in 150-days for certain ANDAs subject to drug shortage and where there was limited competition),

Coin stacks with letter dice - Fees

The GDUFA II Program Fee Estimates – Gulp!

Today, FDA announced the current data they are collecting from which the “Program Fee” will ultimately be calculated for the three tiers of approved application holders.  And while it is really not much of a surprise, based on some back of the envelope calculations we have done in the past, it may be a bit of a shock to some in the medium and highest tiers. 

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First Time ANDA Approvals Announced for 2017

FDA announced (here) that, so far this CALENDAR year through March 24th,  the Office of Generic Drugs has approved 11 first-time generics. That appears to be a good start for the first three months of the year.  All the first-time approvals can be viewed at the link above.

Remember that not all first approvals will immediately be available in the marketplace. 

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This Could Make Your Head Spin

Seems like almost every day a new Federal or State law is proposed to deal with drug pricing for both brand and generic pharmaceuticals. .  The latest entries that appear to be making progress through the legislative process are from the states of Washington and Nevada. One can just imagine that there are specific differences in all the state and federal bills floating around,