May 2017

31
May
OGD Updates Activities Report of the Generic Drug Program – and Other Tidbits Image

OGD Updates Activities Report of the Generic Drug Program – and Other Tidbits

The Office of Generic Drugs (OGD) has provided additional updates to its April 2017 metrics, as reported in the above-referenced document.  Not much excitement there but notable for another low month of Refuse-to-Receive (8), which should be good news to industry.  In addition, Drug Master File (DMF) reviews hit a low for this fiscal year […]

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24
May

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 […]

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19
May

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 […]

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18
May

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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12
May

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 […]

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