FDA

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19 03, 2018

CDRH Planned Reorganization Breaks Down Silos and Focuses Expertise by Product Type

By | 2018-03-19T16:02:55+00:00 March 19th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Enforcement Trends, FDAzilla, Medical Devices|

The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns the expertise into teams by product type and technology.  Individuals from the evaluation and compliance groups for specific product types and technologies will now be on one [...]

22 02, 2018

5 Ways Manufacturing Quality Problems Can Take Down a Company

By | 2018-02-22T17:26:09+00:00 February 22nd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDA-Regulated Industry, Food, Form FDA 483, Medical Devices|

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights into any potential issues that may be brewing. Almost all quality-related warning letters start with an inspection and a 483. While some warning letters result [...]

9 02, 2018

The Ultimate Guide to Researching Your FDA Inspector

By | 2018-02-16T13:24:46+00:00 February 9th, 2018|Biopharma / Pharma, CGMP, FDA, FDA Enforcement Trends, FDA Inspections, FDA-Regulated Industry, FDAzilla, Food, FSMA, Inspection - Features, Medical Devices, Pharma - Featured|

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list.  And while you know you should set up a complete FDA inspection preparedness program, you just [...]

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 [...]

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): […]

9 11, 2017

New CDRH Guidance in October

By | 2017-11-09T16:29:42+00:00 November 9th, 2017|510(k), FDA, FDA-Regulated Industry, FDAzilla, Medical Devices|

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 [...]

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): […]