The Ten Worst Drug Recalls In The History Of The FDA

1) Fenfluramine/phentermine (Fen-Phen)

  • Wyeth-Ayerst Laboratories
  • Recalled: 1997 (after 24 years on the market) No.Of Views: 1239 Read More

Cleaning Validation - Impact on GMP

The topic cleaning validation gained new importan..
No.Of Views: 1147 Read More


Modifying Medicines May Alter Original Quality Characteristics-Requirement for a comprehensive Stability Testing Program

Stability studies are an essential component of pharmaceutical development, allowing evaluation ..
No.Of Views: 1521 Read More


INCURRED SAMPLE REANALYSIS-RATIONALE AND OBJECTIVE

Bioanalytical methods are..
No.Of Views: 975 Read More


Testing of new drugs when the "metabolites are either identified only in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard nonclinical toxicology testing".  It should be of interest to many in the pharma and CRO world.

Aligned ..
No.Of Views: 3487 Read More


The ICH guideline Q3C "Impurities: Guideline for residual solvents" contains specifications for several organic solvents that are used in the synthesis of active pharmaceutical ingredients, intermediate products or raw materials. Due to their, in some cases, high toxic potential, appropriate limit values in the fi..
No.Of Views: 1138 Read More


On the 2nd Oct 2017, the US Food and Drug Administration (FDA) organized a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.

FDA Commissioner Scott Gottlieb spoke at the meeti..
No.Of Views: 1081 Read More


4th October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

"A common format..
No.Of Views: 1533 Read More


The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to acce..
No.Of Views: 1153 Read More


The USFDA has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U..
No.Of Views: 1312 Read More


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