Biopharma / Pharma

//Biopharma / Pharma
10 01, 2018

Is the FDA Now Shifting its Focus to South Korea?

By | 2018-01-13T01:21:42+00:00 January 10th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA Enforcement Actions Against Firms in South Korea by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Several years ago, the FDA began, in earnest, to take more enforcement actions against sites outside the US than they did against sites within the US.  This was simply because the majority of drugs and APIs are produced outside the US.  If we [...]

22 12, 2017

Novel Medicinal Products Part II (The EMA’s Guidance)

By | 2017-12-30T01:41:25+00:00 December 22nd, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends|

The EMA and GMPs for Advance Therapy Medicinal Products by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Manufacturing and testing of Advance Therapy Medicinal Products (ATMPs) is generally significantly different from processes used in chemical synthesis of small molecules or cell-based production of recombinant DNA therapeutic products.  The novelty and complexity of these new products prompted the [...]

21 12, 2017

Novel Medicinal Products Part I (The FDA’s Guidance)

By | 2017-12-30T01:02:10+00:00 December 21st, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends|

The FDA and Its New Guidance on Regenerative Medicine Drugs by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The four guidance we address here are part of the FDA’s announced ‘comprehensive regenerative medicine policy framework’ and support implementation of provisions in the 21st Century Cures Act.  The FDA is actively supporting the development of stem cell and [...]

15 12, 2017

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

By | 2018-01-26T23:04:13+00:00 December 15th, 2017|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Warning Letters, FDAzilla|

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): […]

20 11, 2017

Generic Drugs | A Guidance on FDA Guidance

By | 2017-11-20T21:25:32+00:00 November 20th, 2017|Biopharma / Pharma, FDA, FDA Enforcement News, FDA-Regulated Industry, FDAzilla, quality assurance|

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 [...]

20 11, 2017

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

By | 2018-02-14T12:13:07+00:00 November 20th, 2017|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Form FDA 483, MOST POPULAR, Pharma - Featured|

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 [...]

16 11, 2017

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

By | 2018-01-26T23:06:27+00:00 November 16th, 2017|Biopharma / Pharma, FDA, FDA Warning Letters, FDAzilla|

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): […]

1 11, 2017

Recent Generic Drug Guidance

By | 2017-11-06T01:19:55+00:00 November 1st, 2017|Biopharma / Pharma, FDA, FDAzilla, quality assurance|

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 [...]

18 10, 2017

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

By | 2017-11-27T11:16:55+00:00 October 18th, 2017|Biopharma / Pharma, FDA, FDA Enforcement News, FDA Warning Letters|

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): […]