USFDA Current Affairs

US FDA hikes fee for generic drug approvals

United state Food and Drugs Administration (USFDA) has hiked its fees by 30 percent for new generic drug applications.

Earlier the fee for Abbreviated New Drug Applications (ANDAs) was 58,730 dollars and now has risen by 30 per cent to 76,030 US dollars.

This fee is applicable from 1 October 2015. This move will hit Indian drugmakers as the generic medicines are sold on large scale in Indian market.

Meanwhile USFDA as reduced the fees for facility inspection of foreign companies, this will promote more firms to opt for audit of their facilities by the regulator US FDA.

Further the regulator has also increased the rates of Drug Master File (DMF) by twenty per cent making it 42,170 dollars. All above changed fees is valid till 30 September 2016.

Implications:

  • The hike in fees for new generic drug will put extra burden on small generic drug makers as its costing will increase and eventually will affect the customers  in India who primly opt for generics due to its less pricing.
  • Fees reduction in facility inspection will encourage Drug Company to opt for auditing from regulator.

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USFDA approves first anti-epilepsy pill manufactured with 3D printer

Aprecia’s Spritam becomes first anti-epilepsy pill manufactured with 3D printer to get the US Food and Drug Administration (USFDA) approval.

The specified porous structure of the pill ‘Spritam’ was developed by using ZipDose 3D printing technology by Aprecia Pharmaceuticals.

Designing detail structure of the Spritam pill made it possible for Aprecia to develop a pill that dissolve faster and delivers up to 1000 mg of medication in a single dose.

The pill is supposed to reach in the market by 2016.

Implications:

  • Pill developed under 3D printer will reduce the costing of designing and creating complex structure in lesser time.
  • This pill will improve the medications by delivering exact amount of content to the children and the elders.
  • It will open endless possibilities of personalised medications.

ZipDose 3D printing technology:

The Massachusetts Institute of Technology (MIT) was first to develop Powder-liquid three-dimensional printing (3DP) technology in 1980s. Aprecia started developing ZipDose 3DP technology in 2007 which was designed to enable delivery of high-dose medications in a rapidly disintegrating form. This technology enables the aqueous fluid to stitch together multiple layers of powder to create a wide range of products.

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