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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Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

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

Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary in the manufacturing and testing of the firm’s products.  We provide five recent examples where the FDA appears to increase their enforcement intensity when an acquiring firm with perceived ‘deep-pockets’ enters the game.

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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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Introducing FDAzilla’s New CEO

I’m thrilled to announce that Michael de la Torre is FDAzilla’s new CEO, effective October 19, 2017.  He comes to us after an already-amazing run in executive roles at several companies – leading large teams, collaborating with customers, and expertly scaling businesses. Feel free to connect with him at michael@FDAzilla.com or on LinkedIn. Read the press release here.

I will step down from all my CEO duties, though you will still hear from me regularly via these newsletters and on our blog.  I will also stay actively involved in the company as an owner and Board Chairman.

I have thoroughly enjoyed my seven-year tenure as FDAzilla’s founding CEO, and I’m proud of the team, culture, and reputation that we have built.  Our company will reach newheights with Michael at the helm, and I can sincerely say that our team has never been stronger.

I’m excited for you also, as we accelerate our efforts to provide you with analytics, trending, and benchmarking to make better decisions. Here’s to a great future ahead!

Cheers,
Tony Chen
Chairman, FDAzilla

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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PRESS RELEASE – FDAzilla Announces New CEO

CHICAGO, IL – October 18, 2017

FDAzilla, the leading software platform for GMP intelligence and analytics, is delighted to announce the appointment of Michael de la Torre as its new CEO, effective October 19, 2017. FDAzilla is a vital tool for FDA-regulated industries such as Pharmaceuticals, Medical Devices, CMOs, and Food Manufacturers that need insights and benchmarks on FDA inspections affecting their businesses and supply chain. Continue reading