May 2016

31
May

Stick it to Me!

Today, the FDA announced the availability of a draft Guidance titled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications” (here).  The document discusses the way in which sponsors should document the adhesion of their proposed product with that the of reference listed drug (RLD). Clearly, for a generic transdermal […]

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23
May

FDA’s Most Recent Delay on the Generic Drug Labeling Rule Bodes Well for Industry (Hopefully)?

There are obviously two schools of thought on the Proposed Rule that would permit generic companies to unilaterally update their labeling to include new safety information.   On the consumer advocacy side, and from FDA’s view, it will improve patient safety (but personally I don’t see how).  But when you look at the Proposed Rule (as […]

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20
May
Is FDA Starting to Think (Again) About Cloud Computing Image

Is FDA Starting to Think (Again) About Cloud Computing?

In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.

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19
May

White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain […]

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