November 2015

19
Nov

Boy, FDA Can Move Fast When It Wants to!

The FDA announced the approval of Narcan (naloxone hydrochloride) Nasal Spray as an alternative emergency treatment for accidental opioid drug overdose.  Previously, naloxone hydrochloride, which reverses the effects of opioids very rapidly, was available only as an injection available in a syringe or auto-injector. In a press release issued today (here), FDA notes that, because […]

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17
Nov

Real Time Release Testing – Has its Time Come?

Generally, pharmaceutical manufacturing involves laboratory testing on product sampled at the end of the manufacturing process to assure the product quality as part of the product release.  However, traditional release testing is not the only acceptable approach used to assure the quality product prior to release.  On September 15, 2015, the European Commission published a […]

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13
Nov

Have We Come Full Circle? 

Dr. John Peters, the newly appointed Deputy Director of OGD, just posted a piece on the FDA website on the “Importance of the Physical Characteristics of Generic Drugs”. Dr. Peters also noted that OGD has taken a particular interest in what he termed “Patient-Focused equivalence” or something that I have termed “functionality” when I have been questioned about whether the concept of generic drug “sameness” had taken on new definitions.

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11
Nov

The Battle Over “Natural”

  I usually cover drug and device issues in this blog, but today, I had some “food for thought” as I read a Federal Register Notice (here), in which the FDA is asking for comment on what the term “natural” should mean when used in food products. It seems that over the years many have […]

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