January 2019

31
Jan

FDA Draft Guidance – Notice of Marketing Status of NDAs and ANDAs

The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status.  The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently […]

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28
Jan

Despite the Shutdown, January Approvals Look Fairly Strong.  Will FY 2019 Break Record?

With 5 working days left in January, and despite the turmoil this month has seen, we stand at 58 Full approvals and 17 Tentative approvals reported on the FDA All Approvals page (here) through January 24, 2019. Looking at the first quarter approvals (October thru December), there were a total of 278 full approvals which, […]

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25
Jan

FDA-Required Reports Hit the Web – What Does the Data Show?

Today, the FDA published its required Activities Reports of the Generic Drugs Program (FY 2019) – FDARA Title VIII, Sections 807 and 805 (here).  These reports are published quarterly, as required by law, and outline the following activities: ANDAs subject to priority review, ANDAs with a competitive therapy designation (CTD), and pending suitability petitions (a […]

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24
Jan

Lachman Consultants Services, Inc. Announces Business Exposition Sponsorship of Access! 2019

While concluding its 40th Anniversary Celebration Year with the start of 2019, Lachman Consultants recently announced participation as Business Exposition Sponsor of ACCESS! 2019, the annual meeting of the Association for Accessible Medicines (AAM). (Westbury, NY – January 2019) Lachman Consultant Services, Inc. a leading provider of expert compliance, regulatory affairs and technical services to […]

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24
Jan

Why December ANDA Receipts Were Not Reported – the Light Bulb Goes On

After thinking about our blog post yesterday (here https://www.lachmanconsultants.com/2019/01/the-20-day-window-catch-how-will-it-play-out-and-other-questions/), it now becomes clear why the update to receipts and approvals for the December posting of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm375079.htm) left out the number of December receipts.  It is because the FDA has not yet decided […]

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23
Jan

The 20-Day Window Catch – How Will It Play Out? and Other Questions

The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things.  From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long?  When will the user fee money really run out?  Has FDA […]

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22
Jan

FDA User Fee Carryover Funds Dwindle as the Agency Tries to Keep the Boat Afloat

It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon. Because the Agency cannot accept any new fee-paying applications since […]

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17
Jan

Guidance on TA’ed Applications Deserves TA – Total Attention!

In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note: “We are posting this document on the FDA website […]

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