26
Apr

By the Numbers – OGD Stats Explained and Other Topics

In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting.  As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting. The presenters reviewed the types of required and […]

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21
Apr

Official Approval Numbers, CRLs, and New ANDAs for March Hit the OGD Stats Report

If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen!  […]

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21
Apr

The Hammer Comes Down on Hydroquinone Cream

Used for years as an “unapproved” drug for lightening of skin color, the FDA issued warning letters to twelve firms selling the drug, telling them that hydroquinone is not generally recognized as safe and effective. On August 29, 2006, the FDA issued a Notice of Proposed Rulemaking that would establish that over-the-counter (OTC) skin-bleaching drug […]

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15
Apr

MaPP Out – What Constitutes a Complex Generic Drug? FDA Explains

On April 15, 2022, FDA published a Manual of Policy and Procedures (MaPP) that outlines the FDA thinking on what constitutes a complex drug product for purposes of classification.  A MaPP, as you know, is not an industry tool, but rather an instruction to FDA staff as to the policy and procedure that they  utilize […]

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13
Apr

FDA Has Hinted at It, You Have All Been Waiting, and Now It Is Here – pH adjusters May Be Put to Bed!

Yes, you heard me right; after years of problems caused by those pesky pH adjusters, there is a way around the regulations (and by the way this avenue has always been available for the Agency to utilize).  In a pre-publication of the Federal Resister (here), the FDA says “an ANDA applicant for a drug product […]

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25
Mar
Female Chief Analyst Holds Meeting Presentation for a Team of Economists. She Shows Digital Interactive Whiteboard with Growth Analysis, Charts, Statistics and Data. People Work in Creative Office.

OGD Posts Official February Approval, CRL, and Receipt Numbers and Updates January Stats

We were close with our estimates for February approval actions, but the FDA reported one fewer full-approval action than we did (fifty-nine vs. sixty) and, upon review, note that it was because one of the ANDAs was listed in a separate line item as an action.  Sorry we missed that!  Of the fifty-nine full-approval actions, […]

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25
Mar

March 31 End Date for Alcohol Hand Sanitizer Distribution Under Temporary Policy

In an announcement today, the FDA reminded manufacturers of alcohol-based hand sanitizers that they can no longer distribute products made under the temporary policy, which was withdrawn on December 31, 2021 and gave manufacturers until March 31, 2022 to comply (see the announcement here). The Agency notes that distribution from manufacturers to all outlets, which […]

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22
Mar

Deficiencies Abound – FDA Reports on ER and DR Application Study – Why?

The FDA released a summary table from a study report that was designed to help applicants for extended-release (ER) and delayed-release (DR) products; the FDA is aware of the types of deficiencies that are being seen and is making an effort increase the first-cycle approval rate for these products. The report summary (here) covers 186 […]

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21
Mar
The FDA Inactive Ingredient Database (IID) - Lachman Consultants

The Agency Requests Comments on IID – Will Changes Help or Hinder Drug Development?

In the prepublication of the Federal Register today, the FDA asked for comments on issues related to trying to reduce the confusion on maximum daily intake (MDI) and maximum daily exposure (MDE) limits in its Inactive Ingredient Database (IID).  The industry uses the IID to identify the level of inactive ingredients that may be safely […]

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