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FDA Blog

Generic Drug Pathway

An Overlooked Generic Drug Pathway: 505(b)(2)

By Christina Sanchez Miller

  07/19/2019

  Category: Regulatory

Traditionally the generic drug makers submitted Abbreviated New Drug Applications (ANDA), however more have been opting for the 505(b)(2) regulatory pathway. The...

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Design Control Process for Medical Devices

By Christina Sanchez Miller

  07/19/2019

  Category: Medical device consulting

The FDA requires registered establishments to comply with Current Good Manufacturing Practices (CGMP), and there are specific regulations for each industry, such...

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