The Lachman Blog

27
Jun

CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report

CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report: Analytical Procedure Development Paul Mason, Ph.D., Senior Director at Lachman Consultant Services, Inc., offers analysis and commentary on the draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures. In this informative article, Paul […]

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23
Jun

Beta‑Lactam Antibiotics 2013 Guidance for Preventing Cross Contamination Hits the Street

The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products.  Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]

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21
Jun

Official Approval Numbers for May 2022 and Update on April Stats

Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics.  We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]

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20
Jun

With One Controversial Drug for Alzheimer’s on the Market, Another’s Study Did Not Impress

There is no question that the Alzheimer’s drug Aduhelm has stirred up a lot of controversary.  The action that CMS took related to reimbursement for the drug for Medicare patients and the initial yearly projected cost soured many stakeholders on the product, from prescribers to patients, as well as caregivers and healthcare providers, not to […]

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16
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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16
Jun

Engaging with FDA: Hidden Gems at the FDLI Annual Conference Day 1

The first day of the Food and Drug Law Institute’s Annual Conference started with an excellent keynote address from FDA Commissioner Dr. Robert Califf, who underscored the importance of the FDA engaging with industry to evaluate the promise (as well as risks) of new technology and medicinal products.  Part of that dialogue happens at the individual […]

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14
Jun

Fran Zipp to Present at Medicines for Europe

On Thursday, June 30th, at the Annual Conference of Medicines for Europe, Frances Zipp, President and CEO of Lachman Consultant Services, Inc., will be addressing the audience as a part of the Keynote Speech at the Dolce Sitges Hotel in Barcelona, Spain.  Fran will be addressing humanitarian efforts by industry to provide patients in war-torn […]

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14
Jun
Young man looks at road map near on mountain road, Switzerland

To Measure or Not to Measure, Quality Metrics Is the Question!

The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion.  People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation.  Thus, quality metrics were held tightly close to the chest of business leaders.  Deming identified this […]

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