FDA-Regulated Industry

/FDA-Regulated Industry
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 [...]

23 04, 2018

66 New FDA 483s | April 23rd 2018

By | 2018-04-23T15:35:34+00:00 April 23rd, 2018|Biopharma / Pharma, FDA Enforcement Trends, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks 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 [...]

20 04, 2018

Week of Apr 8th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-04-20T14:16:50+00:00 April 20th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla|

FDA posted 10 warning letters this week: Several for misbranded drugs 2 in the drug area: 1 for a finished drug manufacturer 1 for a compounding pharmacy Note the FDA ‘requests’ that the firm must respond to. These always provide a roadmap for the type of activities expected of manufacturers who might find themselves with similar challenges. Free learning. [...]

19 04, 2018

A Look Into the Foreign Food Facility Inspection Program

By | 2018-04-19T15:36:57+00:00 April 19th, 2018|cGMP Quality Assurance and FDA 483s, FDAzilla, Food, FSMA|

Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA. It can be difficult to navigate new requirements for foreign facilities under FSMA, but [...]

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. [...]

12 04, 2018

93 New FDA 483s | April 12th 2018

By | 2018-04-12T16:03:53+00:00 April 12th, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks 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 [...]

11 04, 2018

3 Strategies to Monitor 1,000+ Suppliers

By | 2018-04-11T14:14:50+00:00 April 11th, 2018|Food, FSMA, Supplier Management|

There is no denying the complexities of FSMA and the demands it places on large companies in the food industry. In-depth record-keeping accompanying extensive preventative control measures are a headache for food processors - at best. The real complications enter, however, when the responsibility of large companies increases exponentially with the requirement of an FSVP. It is difficult to [...]

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 [...]

9 04, 2018

Gaining GCP Expertise: FDAzilla Adds Jamie Colgin As GCP Product Manager

By | 2018-04-09T15:58:45+00:00 April 9th, 2018|Biopharma / Pharma, FDAzilla|

Pleasanton, CA | April 9, 2018: FDAzilla, a global leader in FDA intelligence and analytics, announced the addition of Jamie Colgin as GCP Product Manager -- further filling out its team of industry experts to include a GCP and data integrity professional.Jamie, hailing from Moorpark, CA and recipient of the prestigious Charles H. Butler Excellence in Teaching Award, will focus [...]