The Lachman Blog

17
Nov

Did you miss the Outsourced Facilities Management Learning Experience?

Outsourcing your facilities management program is a great way to reduce the burden on internal resources—but it can also expose your business to greater risk and non-compliance. We’ve got you covered. Earlier this month, Lachman Consultants’ Data Integrity Consultant Patrick Day hosted an insightful and interactive webinar, Outsourced Facilities Management, aimed at helping businesses manage […]

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15
Nov

OTC Naloxone Coming Down the Road?  FDA Would Like to Think So!

The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list.  Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug.  Now, […]

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15
Nov

OGD Extolls Review Enhancement at GRx+Biosims Meeting

At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes.  He outlined a number of these changes from GDUFA II […]

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14
Nov
CHANGES AHEAD: Roadside sign: Trailer mobile warning sign parked by road with words for safety by orange cones

Will There Be Changes to FDA’s Post-Approval Changes Guidances?

One of the closing sessions at the recent Association for Accessible Medicine’s GRx + Biosimilars conference covered Post-Approval Changes to Complex Generic Drugs.  The session included presentations from multiple individuals from FDA, as well as from industry, to provide a breadth of perspective on this subject. As one would expect, the session did offer both […]

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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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11
Nov

Nitrosamines – Where Are We Now?

Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned?  That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference.  The session devoted […]

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09
Nov

CDER Advisory Committee Votes to Progress Quality Management Maturity

Is a mature pharmaceutical quality system really a competitive advantage?  The industry held this as a belief, but progress in a tangible program was always elusive.  On  November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]

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08
Nov

GDUFA III Raises Hopes for Surprise PSG Issuance or Revision

GDUFA III Raises Hopes for Surprise PSG Issuance/Revision Explained at AAM’s GRx-Biosims Conference The product specific guidance (PSG) has been a big help to industry in outlining the requirements for establishing bioequivalence requirements for generic drug products.  OGD has issued over 2000 PSGs since the practice began.  While this has been a big boon to […]

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07
Nov

The ISPE Annual Meeting Highlights Quality’s Mandate in the Age of Digitization

This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready. […]

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