28
Jun

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 […]

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20
Jun
Someone in pain

Opioids Front and Center as FDA Issues Notice of Public Hearing and New Draft Guidance

In two separate Federal Register (FR) notices today, the FDA announced a public hearing (here) to be held on September 17, 2019.  The notice states: This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, […]

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10
Jun

More Time Needed for Comments on Continuous Manufacturing Draft Guidance  

The pre-publication page of the Federal Register Notice posted today (here) a reopening of the comment period for the draft guidance Quality Considerations for Continuous Manufacturing which was originally released February 27, 2019.  That guidance can be found here  . While some (but not too many) firms have embraced the concept of continuous manufacturing, others […]

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30
May
pills and capsules

FR Notice Shows FDA Eager to Entertain/Require Packaging Options for Opioid Containing Products

In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities […]

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14
May

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 […]

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07
May

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 […]

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30
Apr

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 […]

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