23
Dec

IPledge Isotretinoin REMS Prompts FDA Flexibility and Plea to Manufacturers

The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male […]

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10
Nov

AAM’s GRx-Biosims Day 2 – Afternoon Sessions 

The afternoon sessions of the conference that I was able to attend included a discussion of Combination Products and Similarity, and two legal-based sessions, one on Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2) and the other on Generic Drug Case Law. The combination product similarity session described the various permutations of the sameness […]

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12
Aug

Ever See a PANDA In Real Life?  Of Course You Did – You May Even Own One!

In today’s prepublication of the Federal Register listing (here), there is a notice asking for stakeholder comments on the treatment of pre-1962 applications approved as ANDAs that were actually (unbeknownst to most) submitted under section 505(b) of the Act and approved under section 505(c) of the Act, like an NDA.  The historical issues leading to […]

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30
Jul
Doctor holding a clipboard with Safety first, Medical concept

Changes to the Clozapine REMS will Take Effect on November 15, 2021 – Be Prepared

Clozapine was one of the first drugs to have a “REMS” system in place to ensure safe use such that patients developing clozapine-induced severe neutropenia were precluded from getting the drug, which would do further damage, and, thus, avoiding potentially life-threatening scenarios. Initially, the REMS program was independently operated by the innovator and, once the […]

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22
Jul
Businessman Walking Into The City

FDA Field Alert Reports (FARs) far from Clear – Maybe This Will Help

The FDA issued its final guidance on Field Alert Reports (FARs) today (here).  This guidance finalizes the draft guidance of the same title issued on July 19, 2018. FARs have been the subject of much misunderstanding and interpretation regarding when, what, how, and where reports should be sent.  I can’t tell you how many times […]

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19
Jul
Globe

Real World Evidence/ Real World Data Marks Approval of New Use of Existing Product for Transplants

We have heard a lot about the use of real world evidence (RWE) and real world data (RWD) lately in the context of potential approval of new uses of approved drugs.  Well, on July 16, 2021, FDA “approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of […]

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29
Jun

Patient Experience Outcomes Still Puzzle FDA Staff and Stakeholders

In a 33-page report titled Assessment of the Use of Patient Experience Data in Regulatory Decision-Making prepared by Eastern Research Group (here), the views of the FDA and its stakeholders (patients, industry, and physicians) are either leaning towards “we are just figuring it out” (FDA) or “we have no real idea how the Agency utilizes […]

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14
Jun

Now that the Unapproved Drug Initiative Is Back on the Horizon, FDA Makes Noise About Unapproved Prescription Thyroid Drugs

In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows.  The discussion moves on to describe the new generation (well, not too new) of synthetic […]

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23
Mar
Female manager showing stop sign to arguing workers office, conflict resolution

FDA Reviews 20 Drug Products and Determines that They Were Not Discontinued for S&E Reasons

Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)).  Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]

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