Regulatory Affairs

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31
Jan

OGD taking Extraordinary Mission-Critical Step to Improve GDUFA Transparency

By    Jan 31, 2014    FDA Generics Regulatory Affairs

After the issuance of MaPP 5200.3 back in September 2013 relative to communication with industry, voices rang out in pain aas the Generic industry felt as if its lifeline to information concerning the status of its applications were completely cut off. After a cacophony of complaints voiced by both GPhA and a number of firms in the Generic Industry, as well as at least one blogger, OGD has listened. Describing industry’s practices of constant contact with various OGD staff prior to and after GDUFA implementation, Dr. Uhl said “This practice was very resource intensive for us, and sometimes inadequately documented. It could also result in differential treatment of similarly situated applicants, giving rise to fairness and consistency issues.”

OGD recognizes that industry must have some information in order to run its business in an efficient and meaningful way and for making planning, manufacturing, and marketing decisions. In a recently issued (January 28, 2014) memo to the US Public Health Service (USPHS) Commissioned Corps Officers (CCO) assigned to OGD, the program will initiate a rather labor-intensive program to develop a complete inventory of all of each firm’s original applications (not supplements) to provide a one-time snapshot of all of where each firm’s applications are in the OGD review queue.

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24
Jan

Virtual Companies Beware – FDASIA Ratchets Up the Heat

By    Jan 24, 2014    Compliance FDA Generics Regulatory Affairs

In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) inserted a statement into Section 501(a)(2)(B)of the Food, Drug and Cosmetic Act that expanded the meaning of current good manufacturing practice (cGMP). FDASIA’s legislative history tells us that one intention was to require drug manufacturers to employ adequate controls over the materials they purchase. Most would agree that the hazards of unsafe materials justify the need for effective controls and oversight by manufacturers, and most companies are well aware of their responsibility to oversee safety and quality of materials used for manufacturing. FDA’s web page describing FDASIA promises that requirements of the enhanced 501(a)(2)(b)will be reflected in revised CGMP regulations. FDA’s 2014 Regulatory Agenda targets November for issuing a proposed rule. However, enforcement has already begun, and virtual companies are a target.

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22
Jan

OGD Seeking Comments on How to Improve ANDAs

By    Jan 22, 2014    FDA Generics Regulatory Affairs

In a Federal Register Notice to publish on January 23, 2014, OGD is seeking comments and suggestions on how to improve the quality of submitted ANDAs and associated amendments to those applications. In addition, OGD is asking about what specific difficulties firms are having when preparing their ANDAs, so that FDA might help “provid[e] more or better information” to industry.

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15
Jan

FDA Moves to Finalize Plans to Limit Acetaminophen in Prescription Combination Products

By    Jan 15, 2014    Compliance FDA Generics Regulatory Affairs

Three years has come and gone since FDA published its Federal Register Notice (here) requiring drug companies to reformulate their acetaminophen (APAP)-containing combination drug products to contain no more than 325mg of APAP per dosage unit. FDA gave manufacturers three years to make the change or face withdraw of approval of their applicants. In an announcement posted at the very end of the day yesterday, FDA gave final notice that “[I]n the near future we intend to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.”

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16
Dec

Let’s Clean This Up!

By    Dec 16, 2013    Compliance FDA Generics Regulatory Affairs

Today, FDA announced the issuance of a 137 page Proposed Rule designed to investigate whether antibacterial hand soaps are any more safe or effective than washing with simple bar soap. FDA is taking this action to evaluate the safety and effectiveness of these products due to the continued concern about the potential development of bacterial resistance from the widespread use of these agents. The Proposed Rule does not cover does not cover hand sanitizers, wipes or antibacterial products used in the healthcare setting. Rather, it is targeted towards the multitude of bar and liquid soaps used by consumers in routine daily hand and body washes that are advertised as, and contain an antimicrobial agent.

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11
Dec

Getting Ready for October 1, 2014 – the Reality Check is Coming!

By    Dec 11, 2013    FDA Generics Regulatory Affairs

Having previously written about the need for Generic companies to step up the quality of their submissions to avoid refuse-to-receive (RTR) letters as well as avoiding time review penalties for major amendments or multiple minor or unsolicited amendments, I must take a moment to perform a reality check on what happens when the Generic Drug User Fee Act’s (GDUFA) metric kick in on applications submitted after October 1, 2014. As we know, there are no metrics for ANDAs submitted in years one and two of GDUFA; however, years three through five must be looked at with intense scrutiny in light of the good, the bad and the (potentially) ugly aspects of the metrics themselves.

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