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Here it is, 11 days into January 2018, and so far this month (at least at the last check this morning) OGD had approved only two ANDAs. Could it be that they pushed so many out in the first quarter of FY 2018 that there were none left to cross the finish line in early January, or was there something else at play here? We got a hint when a couple...

In today’s global marketplace, industry is responsible for adhering to regulations in all markets that their products are in. Today’s pharmaceutical supply chain also likely contains partners that are across many geographic regions, and regulators expect conformity. In addition, regulators expect proactive compliance, and concerns about a...

To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book. The deadline is approaching and FDA even republished its advice to industry (here) again today! Don’t be left without a retort – be sure to submit your report! On time!

Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality...

Lachman Consultant Services

 •  November 16, 2017

The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the Generation and use of Health-Based...

Lachman Consultant Services

 •  November 13, 2017

From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for...

Lachman Consultant Services

 •  November 13, 2017

As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR). The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated...

Lachman Consultant Services

 •  November 5, 2017

The FDA today posted a revised draft guidance (here) on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II. We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong. Many in the industry have complained that with the stated purpose...

Lachman Consultant Services

 •  October 19, 2017

In a notice on the CDER webpage today, FDA published 32 new draft bioequivalence recommendation documents and revised 19 previously published recommendations. The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”. The two DPI...

Lachman Consultant Services

 •  October 13, 2017

In another flurry of guidance issuances, FDA has provided (what I thought would be) a really good read. I was hoping that the long-awaited Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (here) would have some new insight into choosing which regulatory submission path to follow; however, while being a good...