Generics and the News – Bad Start to the Week or Just Business as Usual?

From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week.  The report on price fixing was met with a response to 60 Minutes May 12,

April 2019 Approval Actions, Receipts, and Complete Responses Posted

Today, FDA posted the official ANDA approval actions and receipts for April 2019.  While the All Approval list reported 93 full ANDA approval actions and 15 tentative approval actions for ANDAs, when we wrote our first blog estimating the approval actions for April on May 3rd  (here) ,   the official FDA numbers for April reported for approval actions was 98 and tentative approval actions was 18,

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.

505(j) or 505(b)(2) – What’s Your Poison?

Today, FDA finalized a guidance document (initially issued in draft in October 2017)that discusses how to best determine if your proposed product should be submitted as an ANDA (505(j)) or an NDA (505(b)(2)).  We first blogged about this here.  The selection of the type of application to submit has been a source of discussion ever since the Hatch-Waxman Act of 1984 created the 505(b)(2) process,

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The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will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,

Accelerated Approval and DTC Advertising – FDA Proposes a Study to Inform Which Direction to Take

In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals.  These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict clinical benefit. 

Sleep Driving, Sleep Walking, and Other Misadventures Prompt Black Box Warning

FDA notes that it “identified 62 cases of complex sleep behaviors that resulted in serious injuries or death after taking insomnia medicines eszopiclone, zaleplon, or zolpidem reported in the FDA Adverse Event Reporting System (FAERS) database between December 16, 1992, and February 27, 2018, and four additional cases reported in the medical literature1-5 between December 16,

Have You Visited the Newly Designed FDA Website?

Well, for us old folks, change is always something that makes us queasy.  The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks).  There were some wrong turns and some dead links along the way,

FDA Announces Enforcement Discretion for Postmarketing Safety Reporting of Combination Products

 

In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4,

New Footnote Raises Questions About Approval Numbers

As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report.  It reads:

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications,