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),

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  On September 15, 2015, the European Commission published a revised draft Guidance,

 FDA Quality Metrics News

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,

Health Fraud – Dietary Supplements Warning Letters


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”.

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 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. 

ISPE “Drug Shortages Assessment and Prevention Tool” is Launched Today

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.

Sit! – Stay! – No IND Needed as Part of Guidance Document is Stayed

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 Deep is FDA Diving in GMP Compliance for Compounding Pharmacies? Just Watch the Recalls and Warning Letters!

With Warning Letters (WLs) and significant FDA 483 observations continuing to confront the compounding pharmacy space, FDA is entering into rounds two and three of inspections to determine if corrective actions have been adequately and timely completed and if the compounding pharmacies understand compliance in this space

To Compound or Not to Compound? That is the Question!

To Compound or Not to Compound? That is the Question!

FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use in the compounding of drug products and has described its interim enforcement policy regarding drugs compounded under Section 505 A (dealing with pharmacy compounding) and Section 503 B (dealing with outsourcing facilities) of the Federal Food Drug and Cosmetic Act.

Single Patient Use – A New Label Term for Parenteral Products

FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. This draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms

FDA to Publish ALL Comments Submitted by Individuals to Dockets on

Well, as someone who routinely reviews postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through.  Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to,

FDA Is Diving Deeper in GMP Compliance for Compounding Pharmacies – A Follow-up

FDA Is Diving Deeper in GMP Compliance for Compounding Pharmacies – A Follow-up

Warning Letters and significant FDA 483 observations continue to confront the compounding pharmacy space. (See previous post here: With over 40% of compounders inspected receiving Warning Letters and nearly 100% receiving critical observations, can this industry respond effectively and meet FDA expectations?

Up the Ladder – Dispute Resolution Draft Guidance Gets 2nd Revision

Today, the FDA released its second revision to its “Guidance for Industry – Formal Dispute Resolution: Appeals Above the Division Level”. The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides additional clarification as to what matters are not appropriate for Formal Dispute Resolution Requests (FDRRs).