16
May

SBIA’s FDA PSG Webinar – OGD Discusses the Dissolution Database 

At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database.  Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6.  […]

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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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12
Mar
supplement bottle Packaging

Guidance on Labeling Changes for Approved OTC NDAs/ANDAs Provides AR Reporting Examples

Today, the FDA published a guidance titled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products” (here) that provides advice on the types of changes to OTC NDA and ANDA product labeling that may be submitted in an annual report.  The guidance provides for “minor changes” that may be made but also […]

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07
Mar
Could Benzoyl Peroxide be the Next Nitrosamine Nightmare - Lachman Blog

Could Benzoyl Peroxide be the Next Nitrosamine Nightmare?

Benzoyl Peroxide is the active ingredient in many acne creams, ointments, gels, and combination semi-solid products for the treatment of acne. These products are sold either by prescription or over the counter. Valisure is the same testing lab that uncovered the nitrosamine impurities in Ranitidine products that developed over the expiration dating life of drug […]

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20
Feb
FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol - Lachman Blog

FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol

In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]

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06
Feb
Paper clipboard with text POLICIES AND PROCEDURES.

CARES ACT – 2024 Update – Big News!

Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement?  The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]

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27
Dec
The Eyes Have it - Lachman Consultants Blog

The Eyes Have it!

On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]

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06
Dec

Reconsideration: Non-Sterile Drug Manufacture – Don’t Let It Bug You!

The bulk of microbiology attention in the drug manufacturing world is laser focused on sterile drug products and the myriad steps needed to aseptically manufacture them. That is certainly with good reason as those drug products carry the highest patient risk should there be microbial contamination. One aseptic manufacturing misstep and the consequences could be […]

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05
Dec
Congress Questioning Delayed FDA Action on Phenylephrine - Lachman blog image

Congress Questioning Delayed FDA Action on Phenylephrine – What About Impact on Other Decongestants?

In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does […]

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