Pharma Blog

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Pharma Blog 2018-02-26T09:29:08+00:00

PHARMA/BIOTECH

BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…

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  • FDA Sent These Warning Letters

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

April 20th, 2018|

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 [...]

  • GMP Regulatory Newsletter: Summary Scan

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

April 16th, 2018|

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, [...]

  • New Featured FDA 483s

93 New FDA 483s | April 12th 2018

April 12th, 2018|

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 [...]

1004, 2018

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

April 10th, 2018|Categories: 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 [...]

904, 2018

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

April 9th, 2018|Categories: 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 [...]

604, 2018

Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies

April 6th, 2018|Categories: Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 8 warning letters this week, including: 1 API manufacturer 1 finished dosage form manufacturer 2 compounding pharmacies DRUGS Keshiva Organics Pvt. Ltd (Maharashtra, India) received a warning letter dated March 15th 2018 based on the outcome of an inspection ending May 31st 2017. The firm is an API manufacturer. FDA identifies that inspections in 2011 and 2014 [...]

504, 2018

FDA Office of Product Quality | Annual Report 2017

April 5th, 2018|Categories: 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 [...]

404, 2018

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

April 4th, 2018|Categories: 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. [...]

3003, 2018

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

March 30th, 2018|Categories: 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 [...]