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Pharma's Top Issue for 2014:Supply Chain Safety
Ed Silverman, Blogger, Pharmalot, 13/01/14  Comment now
Ed Silverman
Now that a new year has begun, the inclination is to look ahead and meet new challenges. But this cannot happen unless the industry builds on or learns from the events of the past year. A few key developments in 2013 are certain to ...
You Can’t Validate a Bad Practice, Can You?
James Agalloco, President, Agalloco & Associates, 02/01/14  Comment now
James Agalloco
Anyone who's been in the healthcare industry for more than a few years has probably heard someone from a regulatory authority say, "You can't validate a bad practice".
Will FDA Change Game for Generic Pharmaceuticals Labeling?
Bikash Chatterjee, President & CTO, Pharmatech Associates, 23/12/13  Comment now
Bikash Chatterjee
In November, the FDA proposed a rule that would allow generic drug makers to update product labeling safety information using the same process as brand drug manufacturers.
Can Emerging Pharma's Leadership Move On to the Next Stage?
Girish Malhotra, President & Founder, Epcot International, 18/12/13  Comment now
Girish Malhotra
This past summer, when news of regulatory noncompliance troubles in the region reached a high point, I asked Indian pharma CEOs in a post on this site whether they had lost their chance to innovate.
Can Expert Gatekeepers Ensure Clinical Trial Transparency?
Ed Silverman, Blogger, Pharmalot, 03/12/13  Comment now
Ed Silverman
Over the past year, the controversy over disclosing clinical trial data has grown more heated. Pharmaceutical industry trade groups have attacked a proposal by the European Medicines Agency, and two drugmakers took court action to ...
Ed Silverman
In a bid to bolster patient safety and the overall quality of pharmaceutical development, India's Office of Drugs Controller has now mandated that all clinical trial sponsors and investigators must videotape the informed consent agreed ...
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