Biopharma / Pharma

//Biopharma / Pharma
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. [...]

30 03, 2018

Week of Mar 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-04-04T16:46:03+00:00 March 30th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

FDA posted 7 warning letters this week. Among those we cover: 1 to an API firm 2 to finish pharmaceutical manufacturers 1 to a device manufacturer We cover these below. The warning letters issued to drug firms all have significant requirements associated with them that firms are to address. We include these requirements because they provide a roadmap of [...]

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 [...]

26 03, 2018

33 New FDA 483s | March 26th 2018

By | 2018-04-04T16:48:51+00:00 March 26th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDAzilla, Food, Medical Devices, Weekly FDA 483s|

Last week, we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your job easier. Learn [...]

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 [...]

22 03, 2018

46 New FDA 483s | March 22nd 2018

By | 2018-03-22T12:59:11+00:00 March 22nd, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

This past week, we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your job easier. [...]

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 [...]

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 [...]