19
Sep

FDA Changes Therapeutic Equivalence (TE) Code for Generic of Prograf 

In an alert yesterday from the FDA (here), the Agency indicated that it was changing the TE code of Accord Healthcare’s product (ANDA 091195) from AB (substitutable) to BX (“not sufficient information to demonstrate that Accord Healthcare Inc.’s tacrolimus oral capsules provide the same therapeutic effect as Prograf (tacrolimus) oral capsules”).  Tacrolimus is used for […]

Read More
18
Sep
Piggy bank on money concept for business finance, investment and saving

Generics and Biosimilars Reap Huge Saving to Consumers 

Once again, AAM reports the data from the IQVIA 2023 U.S. Generic and Biosimilar Medicines Savings Report (here) which demonstrates the savings power from generic drugs and biosimilars.  The Report indicates that, in 2022, the savings realized from the use of generic and biosimilars hit a record $408 billion, of which $9.4 billion was from […]

Read More
15
Sep
If You Are Looking for ANDA Approvals for September, Be Patient - Lachman Consultants

If You Are Looking for ANDA Approvals for September, Be Patient

This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]

Read More
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 […]

Read More
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 […]

Read More
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 […]

Read More
01
Sep

OOS: Whose Line is it Anyway? The Contract Testing Laboratory’s or Sponsor’s?

When it comes to investigating OOS results, a clear line should be drawn between the responsibilities of a contract testing laboratory (CTL) and that of the manufacturer/sponsor. Before we come to the testing part, here are some questions (not all inclusive) to be asked by your firm before selecting a CTL for outsourced testing: (1) […]

Read More
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 […]

Read More
1 7 8 9 51