Petition Form

Revised 505(q) Petition Guidance Published

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that were submitted to the Agency after the original draft was introduced in 2018. 

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. 

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 [...]

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,

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.  

The Yellow Brick Road for Risk Evaluation and Mitigation Strategies

On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions.  The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015.  The update is more of a finalization; the portion of the draft that sets forth the submission procedures for REMS revisions and modifications.

New MaPP Fully Outlines Process for FDA Safety Label Changes

New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs.  It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food,

FDA Proposes a Fix for the DMF Issue for “Deemed to Be a License” NDAs

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 requires that on March 23, 2020, all New Drug Applications (NDAs) for biological products will be “deemed to be a license” under Section 351 of the Public Health Service Act (PHSA).  In December of last year, the FDA published a final guidance as well as a Questions and Answers guidance regarding the complex logistics of this regulatory transition. 

Rules an regulations books with official instructions and directions of organization or team.

Agency Rule List Outlines 81 Items Related to the FDA

The list, published by the Office of Management and Budget, outlines a host of proposed and/or final rules the FDA “hopes” to publish, or at least consider, in 2019.  Given the state of and the bent towards new or additional regulations in the current administration, this seems like an ambitious agenda for the Agency.

The full list can be found here (the FDA is included in the full Health and Human Services list).  

The Treasure Map to Biosimilarity Just Got More Granular

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced.  The increased level of detail and wider breadth of topics gives a significantly better view of the information that the Agency wishes to see in a BLA for a biosimilar product. 

A Deeper Dive on the Biosimilar Interchangeability Guidance Viewed from Our Biologics Expert

On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product.  We did a general post here  and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful and potentially significant changes in the final guidance.

Biosimilar Interchangeability Guidance Hits the Street

The issue of the use of biosimilars and their uptake in the market has been a discussion point since the first biosimilar was approved in 2015.  Today, the FDA issued a long-awaited guidance on how a firm can demonstrate interchangeability of a biosimilar to its reference licensed product. The guidance is titled Considerations in Demonstrating Interchangeability With a Reference Product (which is a bit confusing as it applies only to biosimilars) and can be found here.

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