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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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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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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12
Mar
What is the new FDA Guidance on Q14 Analytical Procedure Development - Lachman Blog

What is the new FDA Guidance on Q14 Analytical Procedure Development?

On March 7, 2024, the FDA adopted ICH Guideline Q14 Analytical Procedure Development, which became official on November 1, 2023. This guidance complements updated ICH Guideline Q2(R2) Validation of Analytical Procedures, which also became official on November 1, 2023 and was adopted by the FDA on March 6, 2024. The Q14 guidance (here) combines a science- and risk-based approach […]

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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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01
Mar
AI Laws on the Move - Lachman Blog

AI Laws on the Move

Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]

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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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16
Feb
Do You Know Your Product’s Impurity Profile - Lachman Blog

Do You Know Your Product’s Impurity Profile?

ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]

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06
Feb
Information for the mass

More Info from the AAM Annual Meeting Regulatory and Policy Meeting

During her session yesterday at the AAM Annual Meeting, Iilun Murphy, M.D. provided additional details on the 2023 OGD metrics, indicating that there were 950 ANDAs approved and tentatively approved (782 and 172 approvals, respectively).  Of the approvals, there were 90 first generics, along with 83 generics with Competitive Generic Therapy Designation, and 111 complex […]

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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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