20
Jul

Everything You May Want to Know About Therapeutic Equivalence (and More!)

While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties.  There may also be some things you did not know, like how a 505(b)(2) application can request a TE […]

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05
Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

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01
Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

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29
Jun

Rescinding Breakthrough Therapy Designation – Guidance Provides FDA’s Thinking

The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.”  The program is designed to “facilitate and expedite” review of promising […]

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06
May

Hold On! That Previously Acceptable Level of Nitrosamine in Your Product is No Longer Acceptable!

Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read:  “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]

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14
Apr

FDA Issues Final Guidance on BA Studies in INDs and NDAs

Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here).  The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019.  That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]

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11
Apr

The Hunt for the Elusive TE Rating for Certain 505(b)(2) Applications – So What’s Holding Up the FDA?

The 505(b)(2) application is really a hybrid of a New Drug Application (NDA) approved under Section 505C of the FFDCA  Act (the Act) and an Abbreviated New Drug Application (ANDA) which is approved under Section 505(j) of the Act.  The (b)(2) pathway was a creation born out of the Hatch-Waxman Act of 1984. It permits […]

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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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