Printout of a DNA sequence chromatogram

Extraneous Chromatographic Peaks – What’s a Lab to Do?

Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i].  This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations. 

Doctor holding a clipboard with Safety first, Medical concept

FDA Denies Public Citizen Petition Asking for a Moratorium on All New Opioid Approvals

In a seven-page response, the FDA denied an April 10, 2019 petition asking the Agency to place a moratorium on the approval of any new opioid products.  The petition by Public Citizen spoke of the public health opioid crisis and asked that the moratorium be continued “until FDA has implemented recommendations from the National Academies of Sciences,

Bioanalytical Laboratories:  What to Do with Variable Internal Standard Response?

For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.”  The Q&A guidance contains five questions, along with the Agency’s current thinking on each topic. 

FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this [...]

Laboratory Instrument Calibration – Are You Covered?

It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments.  There should be a controlled, comprehensive list of the instrumentation within the laboratory,

More is Not Always Better – Extra Testing

When it comes to ice cream and desserts, I must admit the more the better in my opinion.  The same, however, doesn’t hold true for laboratory testing and the resultant data.  All testing performed and data generated must be accountable to ensure the integrity of the data.  Performing extra testing, even if with all good intentions,

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.  The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.

As a reminder, the FDA has not regulated child-resistant packaging since 1973,

Urgent Drug Listing Issue – Check Your Product Status!!!!

Take action now to assure that your facility information, drug listing information, and manufacturing sites are correct and that no changes have been made to any of these items or others that are listed in the FR notice  due to publish on Wednesday (pre-publication notice here).

The Notice indicates registrant’s responsibilities as follows:

Each registrant must list all drugs it manufactures for commercial distribution within 3 days of initial registration (21 CFR 207.45).  

Doctor holding a clipboard with Safety first, Medical concept

Postmarketing Study Reveals Higher Risk of Blood Clots and Death – FDA Approves Boxed Warning

Like many drugs that undergo clinical trials (even larger trials), rare adverse events may not become apparent until well after the drug is in wider use after approval.  In addition, as a condition of approval, the FDA often requires a post-approval commitment to further study the drug.  Such is the case as described in the updated Safety Communication released today by the Agency as FDA announced it approved “a Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz,

Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective.

Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 therapeutic biopharmaceutical products (TBPs).  

Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and to harmonize standards within the industry.