Biosimilars

26
Jun
Rx Prescribing Information Bill Also Introduced in the House - Lachman Blog

Rx Prescribing Information Bill Also Introduced in the House

On June 25, 2025, Reps. Sherrill and Harshbarger reintroduced a bipartisan bill to modernize prescription information (here) and, on June 12, 2025, two senators introduced a similar bill in the Senate (see previous post here). Now we have very similar bills floating around in each chamber. Maybe this is the year that the legislation will pass […]

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23
Jun
Symbol of scales

Revised Q1 Draft Stability Document Issued by FDA

The newly revised and expanded draft guidance titled Q1 Stability Testing of Drug Substances and Drug Products (here) was published today.  This draft guidance represents “a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July […]

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20
Jun
The National Priority Voucher - Lachman Blog

Faster Drug Approvals Under New Program – The National Priority Voucher

An Associated Press article (here) reported that “Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.” This would be accomplished by a team of reviewers similar to those formed under Operation Warp Speed for approvals of the COVID-19 vaccines. “Makary said he will […]

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03
Jun
Do More with Less - Lachman Blog

Do More with Less – Looks Like That Is What the FDA Budget Request Asks

Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]

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01
May
Note pad with word what? why? who? how? when? where?

BPDRs – Is Your Team Ready to Recognize the Need for One?

Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections.  The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency.  Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the […]

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14
Apr
Do You Trust What Your Drug Applications are Saying - Lachman Blog

Do You Trust What Your Drug Applications are Saying?

Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]

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07
Apr
Horses

All’s Quiet on the Eastern Front! Mostly from OGD

Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD.  Communications appear to be quite slow to appear.  Even the Federal Register prepublication page has few FDA postings over the last three weeks.  Another instance of communication lapse: since March 7, 2025, only safety […]

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26
Mar
VHP Revisited 2025 - Lachman Blog

Vapour Hydrogen Peroxide, Still Fragile? A Retrospective Follow-Up on a 2018 MHRA Blog

In April 2018, whilst I was still an expert Inspector at the MHRA, I wrote a blog on vapour hydrogen peroxide. Having recently joined Lachman Consultants, I thought it would be an ideal time to revisit this subject to understand the current situation with this method and perhaps provide insight as to what Lachman could […]

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