18 05, 2018

Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-18T13:12:09+00:00 May 18th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April [...]

16 05, 2018

Ready to Make Your Job a Whole Lot Easier?

By | 2018-05-17T11:13:58+00:00 May 16th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, FDA Warning Letters, FDAzilla, Food, Form FDA 483, Medical Devices|

We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time.

15 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

By | 2018-05-15T14:40:04+00:00 May 15th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this week Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA published Among this later collection are the MHRA GCP Inspection Metrics Changes in the [...]

11 05, 2018

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-11T14:58:07+00:00 May 11th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices. [...]

8 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/29/18

By | 2018-05-08T13:19:00+00:00 May 8th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA 4 from EMA 2 from Health Canada 2 items from Pakistan FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important. To see the complete list of laws, [...]

4 05, 2018

Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-04T12:55:48+00:00 May 4th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them 1 warning letter went to an API manufacturer 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the outcome of [...]

3 05, 2018

The Secret Life of (b)s

By | 2018-05-03T16:09:42+00:00 May 3rd, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices|

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning. I had an aha (and color me red) moment [...]

2 05, 2018

[INFOGRAPHIC] The FDA, Warning Letters, and What to Expect in 2018

By | 2018-05-03T13:49:02+00:00 May 2nd, 2018|Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|

New synthesized data shows that total warning letters continued to climb in 2017. [NEVER MISS A WARNING LETTER: Start your 30 day free trial of the GMP Regulatory Intelligence Newsletter.] Outside the US Of course, this is part of the on-going trend of increased international inspection activity as the FDA "catches up" with the reality that 80% of all [...]

1 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/22/18

By | 2018-05-01T15:45:51+00:00 May 1st, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Guidance documents are available from the FDA and EMA this week across a variety of topics.  Lots to read there from both the FDA and EMA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement publications were busy this week: 3 drug warning letters from [...]