Pharmaceutical Industry

The “Pharmaceutical Industry” category at AssurX focuses on addressing challenges and opportunities within the sector. This section provides insights into quality management, regulatory compliance, and process optimization for drug development and manufacturing. It emphasizes ensuring product safety and efficacy. Discover strategies to navigate complex regulations and enhance operational efficiency. AssurX offers tools and knowledge to help pharmaceutical professionals maintain compliance, improve quality, and drive innovation.

17 08, 2015

US Drug Shortage Hits Patients, Pharmacies the Hardest

By AssurX Blog|2015-08-17T11:17:53+00:00August 17th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Patrick Stone, President, TradeStoneQA The corner drug store is not currently [...]

15 07, 2015

Will New User Fees Fuel More FDA Inspections?
Will New User Fees Fuel More FDA Inspections?

Will New User Fees Fuel More FDA Inspections?

By AssurX Blog|2015-07-15T08:25:57+00:00July 15th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

For FY 2016, FDA is requesting $4.9 billion to support our essential functions a [...]

28 05, 2015

Big Pharma Goes Big for Big Data

By AssurX Blog|2015-05-28T09:54:14+00:00May 28th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry|

When it comes to data, big pharma knows what big pharma likes, according to a ne [...]

11 05, 2015

Should FDA Get Tougher on IRBs?

By AssurX Blog|2015-05-11T08:06:28+00:00May 11th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance Management|

Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Revi [...]

23 04, 2015

FDA’s Action Plan Demands Some Industry Action, Too

By AssurX Blog|2015-04-23T08:10:42+00:00April 23rd, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed [...]

9 04, 2015

FDA Plays Catch Up In Brave New World of Electronic Consent
FDA Plays Catch Up In Brave New World of Electronic Consent

FDA Plays Catch Up In Brave New World of Electronic Consent

By AssurX Blog|2025-05-19T19:09:27+00:00April 9th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

Informed consent (IC) is more than getting a quick signature from a clinical tri [...]

4 02, 2015

Training Management Best Practices for Emerging Life Science Companies
Training Management Best Practices for Emerging Life Science Companies

Training Management Best Practices for Emerging Life Science Companies

By AssurX Blog|2024-07-16T22:25:22+00:00February 4th, 2015|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

No matter how good your written policies are, or how clean a facility you operat [...]

21 01, 2015

Quality Takes Time, FDA’s CDER Reminds Drug Makers

By AssurX Blog|2023-03-06T21:03:25+00:00January 21st, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Scholars still debate how long it took to build the Great Wall of China, but it’ [...]

8 01, 2015

FDA’s CDER Unveils Ambitious 2015 Wish List

By AssurX Blog|2023-03-08T22:49:45+00:00January 8th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The holidays came a little early for the folks at the Center for Drug Evaluation [...]

30 12, 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

By Tamar June|2014-12-30T15:38:32+00:00December 30th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry|

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fisc [...]