06
Feb
Paper clipboard with text POLICIES AND PROCEDURES.

CARES ACT – 2024 Update – Big News!

Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement?  The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]

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25
Aug
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Surviving the Perils of Submitting Controlled Correspondences (Part 2)

In Part 1, we focused on drafting the Controlled Correspondence and tips for formatting and presenting the correspondence, but, after submission, the CC must be accepted by the coordinator to be placement in the queue for review. The office has been very strict, perhaps rightly so, but there have been a few headscratchers too. Some examples […]

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24
Aug
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New ISPE Guide on 503B Compounding

For those struggling with understanding all the complexities of running a 503B compounding facility, a new resource is now available. The International Society of Pharmaceutical Engineers (ISPE) has a new guide coming out titled “503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities” (here). Do you know why compounding exists? Shouldn’t all […]

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24
Aug
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Surviving the Perils of Submitting Controlled Correspondences (Part 1)

Of the many benefits that have come from the Generic Drug User Fee Act (GDUFA) over the years, one has been the addition of response times for the FDA to answer Controlled Correspondences (CCs) that were first negotiated under GDUFA II. The Agency issued an FDA CC guidance, which was finalized in December 2020. Having a […]

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04
Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products.  As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

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21
Feb

New GFI- PSG Meetings between FDA and ANDA under GDUFA

We have seen several changes from FDA with the roll-out of GDUFA III.  Some have been a little frustrating (Controlled Correspondence blog coming soon!), but some have been pretty great!  On February 17, 2023 FDA issued a new GFI, “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA” (here). This GFI seems to point […]

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09
Feb

CARES Act – What’s New for 2023?

It’s that time of year.  Taxes?  Well, yes, but that’s not what I’m talking about.  Instead, I’m referencing the equivalent for those of us in the pharmaceutical industry—CARES Act reporting.  In the last couple of weeks, a flurry of emails arrived for many of us from the FDA, reminding us that: “Under section 510(j)(3) of the […]

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11
Nov
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FDA Gives Some Updates and Some Advice at AAM GRx+Biosims Conference

Day two of the Association of Accessible Medicine (AAM) Generics and Biosimilars Conference, which took place on November 8, 2022, started with plenary session presentations from Dr. Susan Rosencrance, Acting Director, Office of Generic Drugs (OGD), Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality (OPQ), and Donald Ashley, JD, Director, Office of Compliance (OC) with the FDA. […]

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20
Sep

Remote Non-Inspection “Inspections”

Throughout the PDA-FDA Joint Regulatory Meeting that took place September 12-14, 2022 in Washington D.C., the subject of Remote Assessments (RA), also called Remote Interactive Evaluations (RIEs), was repeated over and over again in sessions.  This is not a new thing, as the Guidance for Industry (GFI), “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch […]

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