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The newly revised and expanded draft guidance titled Q1 Stability Testing of Drug Substances and Drug Products (here) was published today.  This draft guidance represents “a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May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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17
Jun
Business man pushing large stone up to hill , Business heavy tasks and problems concept.

Unofficial June Mid-Month Peek at ANDA Approval Actions

Well, we are halfway through June and it’s time to take a look at the unofficial Approval Actions.  Through June 17, 2025 (note that the OGD is usually a day or two behind on approval postings), there were 29 full-approval actions and 12 tentative-approval actions posted on Drugs@FDA: FDA-Approved Drugs (here).  What this means is, […]

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12
Jun
Red apple with bite

Another Bite at the Apple!

Yesterday, U.S. Senators Markwayne Mullin (R-OK) and Cory Booker (D-NJ) reintroduced the “Prescription Information Modernization Act of 2025.”  You’ll likely remember that it has had quite a history.  It’s a commonsense bill that would allow firms to use electronic labeling, eliminating the requirement to include paper package inserts, better known as the prescribing information, while […]

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09
Jun
Unofficial May 2025 ANDA Approval Actions - Lachman Blog

Unofficial May 2025 ANDA Approval Actions—Looks Like a Win!

Well, another good month for approval actions at the OGD as it keeps the approval train in high gear. There were 69 ANDA full-approval actions in May. Please note that three of the full-approval actions were approvals of second strengths for previously approved ANDAs that were likely the result of delayed approval due to patent […]

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05
Jun
FDA Updates Generic Drugs Program Monthly and Quarterly Activities Report - Lachman Blog

FDA Updates Generic Drugs Program Monthly and Quarterly Activities Report—Big Time

Well I don’t know whether it was my continued questioning of the whereabouts of the last three months’ report figures, although I highly doubt it, or the rehiring of some of those policy people previously RIFed that finally gave the OGD enough bandwidth to get to the many things on its plate, with this report […]

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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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