FDA Enforcement News

25 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/15/18

By | 2018-04-25T12:33:41+00:00 April 25th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, Medical Devices|

FDA published several new guidance, both draft and final, this week: 2 are administrative 2 address quality 1 addresses format for submission of vaccines data Bonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7. TGA published 2 relevant items. A fantastic collection this [...]

16 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/8/18

By | 2018-04-24T15:40:43+00:00 April 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week for guidance: The FDA published 6 documents. Nothing from EMA in the areas we follow. WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance. Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA. [...]

10 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/1/18

By | 2018-04-10T13:36:13+00:00 April 10th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It’s been a slow week all around, perhaps spring breaks and the holidays? Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement A very slow enforcement [...]

5 04, 2018

FDA Office of Product Quality | Annual Report 2017

By | 2018-04-05T15:50:13+00:00 April 5th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

A previous blog entry addressed the Office of Pharmaceutical Quality ‘One Quality Voice’ effort, an aspirational view of FDA’s efforts to ensure coordination in the review, inspection, and approval process as well as post-approval oversight of both facilities and products. Shortly after that publication, FDA’s Office of Product Quality published their first annual report that we address in this [...]

4 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/25/18

By | 2018-04-10T13:22:07+00:00 April 4th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

Laws, Regulations, Guidance, and Concept Papers A slow week for guidance publication:  2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. [...]

28 03, 2018

The FDA’s “One Quality Voice”

By | 2018-03-28T13:46:24+00:00 March 28th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

FDA’s report on pharmaceutical quality for the 21st Century in 2004 put forth their vision for reorganization within the FDA that would strengthen their ability to ensure drug quality. As part of FDA’s reinvention and modernization, they created the Office of Product Quality ‘to promote “One Quality Voice” through the integration of review, inspection, surveillance, policy, and research for [...]

27 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/18/18

By | 2018-04-10T13:28:55+00:00 March 27th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers We have another slow week in the publication of guidance: FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compounding EMA published 1 item addressing pharmacogenomic practices CDSCO (India) and TGA each published 1 We see the usual collection of non-guidance items from MHRA, EMA, FDA, and [...]

23 03, 2018

Week of Mar 11th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-03-23T14:22:21+00:00 March 23rd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Warning Letters, FDAzilla, Medical Devices|

FDA posted 11 warning letters this week: 3 were issued to duodenoscope manufacturers (we identified those last week) 2 warning letters went to device firms 1 to a contract testing laboratory in France 1 to a compounding pharmacy DRUGS/CONTRACT TEST LABORATORY: Quali-Controls & Quali-Controle C.E. BAC (Meru, France) received a warning letter on March 5th 2018 based on the [...]

20 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/11/18

By | 2018-03-20T10:25:51+00:00 March 20th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It’s a very light week for new guidance documents, but do note that the FDA has two in the area of tobacco. The non-guidance publications include the usual collection from FDA, EMA, MHRA, HPRA, and TGA. The FDA also released the form 483 for a recent publication of Biocon’s facility in Malaysia. Want [...]