29
Sep

Validation Still the Key to Success

The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop.  The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]

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22
Sep

AAM 2022 Report on Generic and Biosim Savings for 2021

It’s no surprise that the use of generic drugs saves consumers and health plans big money.  Now, add the savings being achieved from biosimilars (expected to increase significantly over the next year or two) and the amount is almost staggering! The just-released report, which can be found here, provides details that support the findings that […]

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15
Sep

It’s Elementary – FDA Guidance for Na, K, and P Labeling for Rx and OTC Products

Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking on the standardization, proper format, and necessary information for the contents of these elements in OTC and prescription drug labeling.  Right now, labeling for OTC products […]

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14
Sep
Blizzard

Countdown to Pink Slips

The User Fee negotiations are still underway and those discussions must be finalized soon or you may not have many folks to speak to at FDA.  Yes, there is some carryover money but no one knows for sure how employees will react if pink slips go out.  It now looks like September 15th will be […]

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13
Sep

Right to Try Final Rule for Reporting Under the Act To Publish On Wednesday

In today’s prepublication of the Federal Register appears the final rule entitled Annual Summary Reporting Requirements Under the Right to Try Act (here). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina, Right to Try Act of 2017 (Right to Try Act), was signed into law on May 30, 2018. This Act provides an […]

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09
Sep

After ADCOM’s Favorable Nod for ALS Drug, Will Another Shoe Drop? Just Saying!

With the demise of the Alzheimer’s drug aducanumab after the FDA’s accelerated approval and CMS’s actions to raise Medicare premiums in anticipation of huge demands based on its proposed pricing, we may now face another similar situation and that is with a drug for amyotrophic lateral sclerosis (ALS).  After a 7-2 favorable vote by the […]

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06
Sep

OGD Approval Actions – New High For FY 2022 (Unofficial Totals)

It appears that the OGD has hit a new high for total approval actions in August, judging by the unofficial numbers gathered from the available FDA databases as of this morning. Yes, that’s right-a total of ninety-five approval actions (seventy-four full-approval and twenty-one tentative-approval actions), which eclipses the ninety-four total full- and tentative-approval actions (eight-four […]

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19
Aug

Mid-Month Peak at August 2022 ANDA Approval Actions

Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions.  Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]

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14
Jul

Compounded Drug Surveillance – Mitigation of Risk Is the Payoff

Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here)  which provides an overview of FDA’s Compounding Incidents Program.  It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]

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13
Jul

Is It Time to Rethink User Fees?

In an article titled “A Bipartisan Case Against US FDA User Fees?” published in the Pink Sheet on July 11, 2022, Michael McCaughan discusses two of the no votes from senators on reauthorization of the user fee program.  McCaughan writes that Senators Richard Burr and Bernie Sanders “expressed concern that the increasing fees contribute to […]

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