FDA approved the first genetically engineered fish which they have determined is safe for our food supply. The fish is engineered to grow faster, which will, of course, make it a more abundant food source. Who knew a fish could be approved through a new animal drug application (NADA)? Not me!
The Office of Generic Drugs (OGD) would like the generic industry to know that it is poised to bring home the bacon on approvals. The industry has the table set, but, according to some, the meal has yet to be served. This “trust, but verify” position comes at a time when the GDUFA II negotiations are just underway.
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),
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 On September 15, 2015, the European Commission published a revised draft Guidance,
On 11/11/15, at the ISPE Annual Meeting in Philadelphia, Russ Wesdyk from the FDA Office of Surveillance spoke about quality metrics. Since the FDA Metrics Guidance is still in draft and the comment period is still open, he didn’t provide any specifics about the Guidance itself. Since its issuance, industry has been studying and commenting on each and every aspect of the Guidance,
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.
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on.
A little more than a year ago, I gave a presentation on FDA hot topics. One of the areas that was identified in my presentation was a potential for an increase in FDA enforcement efforts relative to dietary supplements, their claims, and the issues of new drug claims. I stumbled across a posting on the FDA webpage that gave examples of dietary supplement Warning Letters that were identified by FDA under the general classification of “Health Fraud”.
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 weighed in on what the definition should be and some even believe that the term should be banned from use in the food industry because it has no standard or defined meaning.
The Office of Generic Drugs (OGD) issued MaPP 5200.7 (here) today that addresses the need for filing review for certain amendments and supplements to ANDAs. We all know that an Original ANDA must go through the filing review to determine if the ANDA is substantially complete to permit a substantive scientific review.
Today, at the ISPE Annual Meeting in Philadelphia, an important new tool in the battle against drug shortages will debut. The “Drug Shortages Assessment and Prevention Tool” drew on feedback from ISPE 2013 Drug Shortages Survey and 2014 Drug Shortages Prevention Plan, and focuses on the prevention and practical application to help industry assess its preparedness for mitigating drug shortages.
Fran Zipp, President of Lachman Consultants, presented at the 2015 ISPE Annual Meeting, November 8-11 at the Philadelphia Marriott Downtown. She spoke about the launch of the ISPE Drug Shortage Assessment and Prevention Tool, on Monday, November 9 at 10:45 AM. For a preview of the tool, please see this article authored by Fran in November’s issue of Pharmaceutical Engineering.
Last Friday, FDA published a Notice in the Federal Register (here) relative to staying a portion of its September 2013 Guidance Document titled Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND. The Agency indicated that, based on comment received on various sections of the final Guidance,
How does the Office of Generic Drugs (OGD) make a determination to revise an existing bioequivalence (BE) guidance? What happens to the requirements for drug product under development or those products that are approved when a BE guidance is revised? These questions were addressed by Dr. Robert Lionberger and Dr. Larissa Lapteva in a session at the GPhA Fall Tech Conference.
As you know, the issue of controlled correspondence has historically been a contentious issue between the Office of Generic Drugs and the generic industry mostly related to timing of the response. The situation is not different today but the contention addressed today is more about the new definition of controlled correspondence and who may submit them.