Pharma Blog

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Pharma Blog 2018-02-16T13:15:00+00:00

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

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  • 5 Ways Manufacturing Quality Problems Can Take Down a Company

5 Ways Manufacturing Quality Problems Can Take Down a Company

February 22nd, 2018|

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights [...]

  • Generic Drug Application Submission and Assessment

Generic Drug Application Submission and Assessment

February 21st, 2018|

The FDA published two related guidance for generic drugs in January:  the 11-page MAPP 5241.3 titled 'Good Abbreviated New Drug Application Assessment Practices' and a 30-page heavily footnoted draft guidance titled ‘Good ANDA Submission [...]

  • GMP Regulatory Newsletter: Summary Scan | Week of 2/11/18

GMP Regulatory Newsletter: Summary Scan | Week of 2/11/18

February 19th, 2018|

Laws, Regulations, Guidance, and Concept Papers The week of February 11, 2018 was slow in the publication of guidance documents. The FDA published three, and the EMA did not publish any in the areas [...]

1602, 2018

Week of Feb 4th 2018 | FDA Sent These Warning Letters for Pharma Companies

February 16th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Warning Letters, FDAzilla|

The FDA published only seven warning letters this week. Of [...]

902, 2018

The Ultimate Guide to Researching Your FDA Inspector

February 9th, 2018|Categories: Biopharma / Pharma, CGMP, FDA, FDA Enforcement Trends, FDA Inspections, FDA-Regulated Industry, FDAzilla, Food, FSMA, Inspection - Features, Medical Devices, Pharma - Featured|

The trick with any FDA [...]

702, 2018

20,000 FDA Warning Letters

February 7th, 2018|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|

Here at FDAzilla, we’re excited to report that we have [...]

2501, 2018

If You Didn’t Document It, It Didn’t Happen

January 25th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDAzilla, Medical Device - Featured, Medical Devices|

A Guest Post from Oliver Yu, CTO, FDAzilla A core [...]

1801, 2018

FDA Issued 42 Product Recalls, Import Alerts, and Consent Decrees in December 2017

January 18th, 2018|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla|

Here’s our monthly summary of product recalls, import alerts, consent [...]