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 [...]

13 10, 2017

FDA Issued 36 Product Recalls, Import Alerts, and Consent Decrees in September 2017

By | 2017-11-27T11:21:48+00:00 October 13th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

25 09, 2017

The Heightened Importance of Contract Manufacturing Organizations

By | 2017-11-27T11:26:41+00:00 September 25th, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals.  Hovione Pharmaceuticals offers a range of contract services including but not limited to, product development, manufacturing of API and drug products, and analytical support. [...]

25 09, 2017

New FDA GMP Inspection Model

By | 2018-02-14T11:48:18+00:00 September 25th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, quality assurance|

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 [...]

14 09, 2017

FDA Issued 66 Product Recalls, Import Alerts, and Consent Decrees in August 2017

By | 2017-11-27T16:31:45+00:00 September 14th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, Medical Devices|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

23 08, 2017

Summer Enforcement Actions for Compounding Pharmacies and Outsourcing Facilities

By | 2017-12-01T22:02:49+00:00 August 23rd, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|

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. [...]

22 08, 2017

US-EU Mutual Recognition Agreement of 2017

By | 2018-02-16T13:19:13+00:00 August 22nd, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, Medical Device - Featured, Medical Devices, quality assurance|

A Long Time in the Works by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the US FDA and the European Union (EU) inspectorates has been in the development since 1998 and was formalized this year. This agreement was driven by [...]