Compliance

30
Apr
Quality Agreements Image

Important ISPE Meeting on Quality Risk Management Sustainability

On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management.  Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]

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29
Apr

Day Two of the Generic Drug Forum – Morning Sessions

Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives.  Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]

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29
Apr

Day Two Generic Drug Forum Afternoon Sessions

The afternoon started out with a discussion of Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms.  The presentation provided an introduction to the understanding of the purpose of biopharmaceutics risk assessment and a discussion of how to perform the assessment which focused on understanding the role of in vitro dissolution […]

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23
Apr

Paper Inserts for Prescription Drugs – a Dinosaur That Won’t Go Away

An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry.  Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]

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15
Apr

Remote Inspection Guidance Now A Reality But Will It Solve the Backlog of Inspections?

Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here).  The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]

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25
Jan

Compliance/Enforcement Activity, the Slow Down, and Predictions

Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry.  COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry.  High […]

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08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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24
Nov

Price Saving’s Short-Sighted Action by HHS – Unapproved Drug Initiative – Cancelled!

I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market.  Firms need to […]

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23
Nov

Lachman Consultants Wishes You a Happy Thanksgiving

At first blush, it does not seem like we have that much to be thankful for in 2020, between the pandemic, polarized political views, a contentious election, worry about loved ones, quarantine and stay at home orders, restaurants closing and opening, only outside eating, and hospitals jammed packed and people dying, jobs disappearing and Federal […]

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12
Nov

Mission Critical Inspections, What About Me?  What’s a Body to Do?

Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections.  Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated […]

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