Category Archives: FDA

FDA Sent These 3 Warning Letters for Pharma Companies | November 2017

We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained.

From pharmaceuticals in China and India only, here they are (starting with the most recent):
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Generic Drugs | A Guidance on FDA Guidance

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

On November 1, 2017, we published a blog that addressed a large collection of newly issued guidance for the generic drug industry.  With this post, we continue with another three generic drug guidance that were issued recently.  Consistent with the previous collection, many of these find their roots in GDUFA legislation.  This time we address three guidance documents.  Regulatory affairs departments should carefully read the first two that include detailed specifics on who needs to pay what and when.  The last guidance addressed here should be read carefully by groups who develop filing strategy.  It appears most problematic and may not provide the relief or speed as it may have intended.

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FDA Sent These 6 Warning Letters for Pharma Companies | October 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate.

From pharmaceuticals in Wisconsin, India, and more, here they are (starting with the most recent):
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New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

The FDA has been on a bit of a tear in publishing guidance for devices and generic drugs.  Here we address the CDRH guidance issued between September 29th and October 25th 2017 and provide summaries of their content.  Seven guidance listed below are final, and one is published for comment.  Many are associated with requirements in the Medical Device User Fee legislation, MDUFA.  Expect more of these moving forward into the MDUFA IV era.

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Recent Generic Drug Guidance

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

October has so far seen a flurry of guidance publications focused on generic drugs.  It’s unusual to see so many guidance on one kind of product published almost simultaneously — though the device area seems to be making the same effort!  Many of the generic drug guidance are published to implement requirements in the Generic Drug User Fee Act (GDUFA I or II).  Two of the guidance documents are final, and one is a MAPP; the others are drafts available for comments that the FDA will consider prior to finalizing.  In addition, the FDA published thirty-two (32) new draft bioequivalence guidance and nineteen (19) revised guidance to assist in the development of generic drugs.  We won’t cover the bioequivalence guidance here, but if you operate in the generics area, please look at them.  Let’s take each of the others in turn to briefly see what they cover.

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FDA Sent These 5 Warning Letters for Pharma Companies | September 2017

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use.

From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent):
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New FDA GMP Inspection Model

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted.  The FDA recently made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs.  This model continues the FDA’s efforts to refine inspection operations as described in their recent reorganization of the Office of Regulatory Affairs (ORA).   It aligns and supports the New Inspection Protocol Program.  The MRA between the EMA and FDA allows health authorities to maximize their abilities to focus inspection efforts on high risk sites and rely on each other’s inspection outcomes.  Taken together, these changes will permit:

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FDA Sent These 11 Warning Letters for Pharma Companies | August 2017

We took a snapshot of the 11 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to keep drug product infestation free to failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the proper education, training, and experience.

From pharmaceuticals in China, Georgia, and more, here they are (starting with the most recent):
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Summer Enforcement Actions for Compounding Pharmacies and Outsourcing Facilities

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

July and early August 2017 saw another uptick in FDA actions associated with compounding pharmacies/outsourcing facilities.  In the past few years, the FDA has placed a disproportionate effort towards enforcement actions for these facilities.  We have addressed this focus and the history of these facilities in a previous blog.  The FDA published twenty-one (21) 483s and six (6) warning letters issued to these facilities in July 2017.  It’s clear that FDA’s extreme focus on these facilities continues and the compliance problems for these facilities have not been appropriately addressed. And, more problematic for me, is that firms do not appear to be learning from the enforcement actions taken against others in this area.   In addition, there have been several recalls of unexpired products and notices to healthcare professionals regarding adverse events apparently associated with these products and two consent decree agreements. Let’s look at these in turn:

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