The Lachman Blog

31
Mar

The Skinny Label Gets Some Food for Thought that May Fatten Up Its Standing

I’ve been blogging about the chilling and hugely negative impact that the court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, have on the delicate balance between the generic and brand‑name industries struck by the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act).  I won’t recount the […]

Read More
27
Mar

Face to Face Meetings at OGD – Get in Line and Get Ready!

That’s right! Get ready, get set, GO! Beginning March 27, 2023, OGD will start to accept requests for Face to Face (FTF) meetings again. However, according to the FDA announcement, FTF meetings will be limited to “pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.” Access may […]

Read More
24
Mar

FY 2023 OTC User Fees Announced

This morning, the FDA published the OTC User Fee rates for FY 2023 in a Federal Register notice (here); these rates cover fees for OTC manufacturing facilities (MFD), contract manufacturing organizations (CMO), and OTC monograph order requests (OMORs) for which there are tier 1 and tier 2 requests.  A comparison of the first three fiscal years is presented […]

Read More
22
Mar
FDA Biosimilar Educational Resources - Lachman Consultants

New Biosimilar Educational Resources for Patients and Caregivers Released by FDA

Yesterday, the FDA released additional educational material to aid patients and caregivers in understanding how biosimilars are approved and to explain the differences between and among original biologic products and biosimilars.  With more and more biosimilar products hitting the market, these educational tools are designed to make the public more aware of options that they […]

Read More
21
Mar

We’ll be looking for you at the 2023 PDA Annual Meeting

Visit with Lachman Consultants at Booth #600. The PDA Annual Meeting is a must-attend event for professionals in the pharmaceutical and biopharmaceutical industries. The three-day 2023 event is being held on Monday, April 3rd to Wednesday, April 5th at the Hyatt Regency New Orleans. As a leading forum for knowledge-sharing and networking, this year’s event […]

Read More
16
Mar

FDA Issues Draft Guidance with Definitions of Terms in Drug Supply Chain Security Act (DSCSA)

Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here).  The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]

Read More
1 2 188