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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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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),

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New Report, Same Problem? I Am So Confused!

Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month.  In addition, the FDA Approved Drug Products daily listing (here) can now be run for a 7- or 14-day period. 

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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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OGD Approvals Look About the Same

According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report of the Generic Drug Program in a few days.

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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,