The Lachman Blog

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26
Sep
3D Stars with In the Congratulations Word

New Boss at AAM

According to a post yesterday (here), the Association for Accessible Medicines (AAM) Board of Directors has announced the appointment of John A. Murphy, III as the association’s President and Chief Executive Officer.  Mr. Murphy will join AAM in October from the Biotechnology Innovation Organization (BIO) where he served as Chief Policy Officer. Mr. Murphy is a lawyer and, […]

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23
Sep

The value of Lachman Consultants expertise and experience will be on display at The MedTech Conference.

Visit with Lachman Consultants at Exhibit Hall E, Booth 626. We hope to see you at The MedTech Conference at the Metro Toronto Convention Center in Toronto, Canada, October 15-17, 2024. It features world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology. This fast-growing event is a gathering of the world’s top medtech […]

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23
Sep
Lachmans Own Charles Gibbons Speaking at CPhI Global - blog image

Charles Gibbons to Speak About Data Integrity at CPhI Global

Lachman Consultants is delighted that Charles Gibbons has been invited to speak at the CPhI Global Conference 08 Oct-10 Oct 2024 Fiera Milan, Italy! Session: Deep Dive: Navigating Data Compliance Standards in Pharma Speaker: Charles Gibbons, Director Data Integrity & Data governance Time & Date: October 8th 15:45-16:10 Location: Manufacturing 5.0/Hall 5   Not sure […]

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20
Sep
OGD Effort to Comply with ICH M13 in High Gear – Drops Fed Study Requirements for Hundreds of Products - Lachman Blog

OGD Effort to Comply with ICH M13 in High Gear – Drops Fed Study Requirements for Hundreds of Products

Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]

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13
Sep
Shot of an asian businessman shouting into a megaphone against a studio background

Now Hear This!

Reviewed “under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device,” the Agency has approved an OTC software solution that is compatible with certain Apple AirPods Pro headphones and provides, according to the FDA release […]

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12
Sep

Newest Chapter in the Nitrosamine Saga – A Revised Guidance and FDA Acknowledges Their Differences

The FDA has updated the original nitrosamine impurity guidance after publication last year of Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (here), also known as the RAIL guidance, caused a few disconnects between the two guidances.  Now that we’ve all had more time to carefully read and absorb the updates in the […]

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