11
Sep
OTC Monograph Request Fees for FY 2024 - Lachman Consultants

OTC Monograph Request Fees for FY 2024

This morning, the FDA published the OTC Monograph request Fee rates for FY 2024 in a pre-publication Federal Register notice (here); these rates cover fees for OTC monograph order requests (OMORs) for which there are Tier 1 and Tier 2 requests. The distinction for the two classifications of OMORs are a Tier 1 request (usually […]

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08
Sep
August 2023 Delivers for ANDA Approval Actions Unofficially - Lachman Consultants

August 2023 Delivers for ANDA Approval Actions (Unofficially)

We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March […]

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05
Sep
Guidance on Post-Warning Letter Meetings Will They Provide Some for Only a Special Few - Lachman Consultants

Guidance on Post-Warning Letter Meetings: Will They Provide Some for Only a Special Few?

The GDUFA III commitment letter (here) outlined a number of industry-requested improvements to the GDUFA program. One such request related to the age-old problem of timely resolution of compliance problems resulting in a warning letter at a facility and the clearance of that warning letter. Specifically, in section VII(D) of the commitment letter, the “FDA agreed to […]

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01
Sep
Quality Management Maturity Document Released by FDA

Quality Management Maturity Document Released by FDA

The FDA issued a White Paper titled CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, designed as the next step in the evaluation of key quality assessments designed to identify a high level of commitment to quality management at a manufacturing firm. In the document, the FDA cautions that “Information […]

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30
Aug
Another Year Reprieve for Another Aspect of Track and Trace Legislation - Lachman Consultants

Another Year Reprieve for Another Aspect of Track and Trace Legislation

This morning, the FDA published a revision to the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies guidance originally issued in draft in 2019 and then finalized in 2020. The revision provides for another one-year delay in enforcement for the […]

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29
Aug
Vyvanse_BlogImage_LachmanConsultants

Vyvanse Shortages Should Be Resolved but What Will the Market Do?

On August 25, 2023, the Office of Generic Drugs approved a total of 14 different applications for lisdexamfetamine dimesylate products after the expiration of a patent on August 24, 2023. (This is the first time in a long while where I remember this many applications being approved on a single day.) While this is good […]

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25
Aug

FDA Hears Industry’s Cry – Enforcement Policy Described Ahead of November 27, 2023 DSCSA Deadline

For months (if not years), we have been hearing alarms from industry trading partners who are subject to requirements for enhanced drug distribution security under section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law […]

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23
Aug
Here’s a Surprise! FDA Warns About Undeclared Active Ingredients in Sexual Enhancement Products!

Here’s a Surprise! FDA Warns About Undeclared Active Ingredients in Sexual Enhancement Products!

Today FDA has warned consumers (here) that the products listed below that are offered for sale in the US contain undeclared active ingredients that can be dangerous for some users. This is not really a surprise as unscrupulous manufacturers and distributors try to cash in on patients with erectile disfunction or on users that merely […]

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22
Aug

Two Bulk Drug Substances Are Denied for Inclusion on Bulk Drug List for 503B Compounders

In a Federal Register Notice, FDA explains that ephedrine sulfate and hydroxychloroquine sulfate are not to be included on the bulk drug list for use in compounding by 503B outsourcing facilities (here). As mentioned by the Agency “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to […]

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