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This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in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. 

Question Marks on Blackboard

Silver Spring – We Have a Problem! August Approval Numbers Don’t Add Up!

OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here).  However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative approvals (13). 

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,

Effective Post Market Supplier Strategy for Combination Products

A combination product, which is a combination of a drug or biologic with a device delivery constituent part, are typically designed, developed, and maintained under a robust manufacturing process. This article is targeted for companies that have existing combination products on the market or are prepping their quality management systems to be compliant with the [...]

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 [...]

Considerations for Analytical Method Validation Life Cycle Controls

A question that may be raised by industry professionals is, “How does the upcoming ICH Q14 guideline impact the methods that I currently use?” The FDA’s July 2015 Guidance for Industry: “Analytical Procedures and Method Validation for Drugs and Biologics” references analytical method development, the use of statistical tools during method validation, and life cycle [...]
stack of one hundred dollars notes

FDA Announces MDUFA and Outsourcing User Fee Rates for FY 2020 – All Fees Higher

In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020.  The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020.

The medical device fees are provided in the charts below,

Can We Call It the Affirmation of a “Beautiful Friendship”?

FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.  The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was initiated in 2015.

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live news reporting and sports events in real time.  

Real World Data and Evidence Coming to an Application Near You?

The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will receive Real World Data (RWD) and Real World Evidence (RWE) and the potential use of each.  After reading the draft guidance, it seems to me that the industry is still far away from being able to rely on RWD and RWE for use in supporting initial application approval,

Big Year for NMEs at FDA

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here.

It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term. 

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update

It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions.  November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively).  The 128 total approval actions obviously ties last month record number of approval actions for a single month.

Of interest,

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