The Lachman Blog

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02
Apr

Ophthalmic Drug Product PSG Publishes Under Unusual Circumstances 

Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here).  As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]

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28
Mar

FDA Sets OTC Drug Monograph Facility User Fee Rates for Fiscal Year (FY) 2024 and They Are UP! 

Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes the FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC Monograph order requests(OMORs).  OMOR fee rates for Fiscal Year (FY) 2024 were published on September 12, 2023 (see blog post […]

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27
Mar

FDA Warns of Danger for Unapproved Topical Products Containing Lidocaine 

In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs.  The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.”  These products are being marketed at concentrations above […]

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27
Mar

Will you be joining us at the American Biomanufacturing Summit?

You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]

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26
Mar

FDA Lowers the Number of Required BA/BE Reserve Samples in Revised Guidance 

The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome.  Now, after twenty years of concern expressed by the industry, […]

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22
Mar
Flash Drives Risks Hiding in your Data Backup Strategy - Lachman Blog

Flash Drives: Risks Hiding in your Data Backup Strategy

Do you struggle with modern data backup methods on industrial automation? Sometimes these “islands of automation” are not conducive to well-established methods when there is no apparent network connection. In cases such as these, a frequent choice is to use a flash drive. This technology is available in most Human Machine Interfaces (HMIs) and Programmable […]

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21
Mar
New CVM Draft Guidance for Industry 285 – Changes Are A-Coming - Lachman Blog

New CVM Draft Guidance for Industry #285 – Changes Are A-Coming

Since the retirement of CVM Guidance for Industry (GFI) #42 “Animal Drug Manufacturing Guidelines – Series of Four Guidelines,” which was withdrawn in October 2019, the animal health industry has been anticipating guidance from the CVM on these topics. The first of four anticipated guidance documents was issued on March 18, 2024 as a draft (here), and […]

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19
Mar
Displeased Woman Waving Her Finger Against A Pink Background

Demonstrably Difficult to Compound List Proposed Rule Issued by FDA – Will Compounders Balk?

The FDA has been working with the Pharmacy Compounding Advisory Committee (PCAC) since the year 2000 to develop a list of drug products that present demonstrable difficulties for compounding.  Concerns relative to bioavailability, variations in batch-to-batch consistency, and dosage-form release characteristics that could present significant safety (or other) issues are outlined in and provide a […]

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18
Mar
FDA Continues Execution of HHS AI Strategy - Lachman Blog

FDA Continues Execution of HHS AI Strategy

The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]

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