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FDA Publish Guidane on Media Fills for PET Drugs

admin — Mon, 24 Oct 2011 12:04:42 +0000

FDA Publish Guidane on Media Fills for PET Drugs

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This guidance is intended to help manufacturers of positron emission tomography (PET) drugs meet the requirements for the Agency’s current good manufacturing practice (CGMP) regulations for PET drugs (21 CFR part 212). Most PET drugs are designed for parenteral administration and are produced by aseptic processing. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, most notably bacterial endotoxins. A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.

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FDA Publish Guidance on PET Drug Applications

admin — Mon, 10 Oct 2011 09:10:12 +0000

FDA Publish Guidance on PET Drug Applications

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On December 9, 2009, FDA issued a final current good manufacturing practice (CGMP) regulation for the production of positron emission tomography (PET) drugs. Under the requirements of section 121 of the Food and Drug Administration Modernization Act (FDAMA), within two years following this publication date, an NDA or ANDA must be submitted for any PET drug marketed for clinical use in the United States.
This guidance is intended to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging for the indications cited in Section III (below). FDA approval of an NDA or ANDA will make it possible to market these PET drugs for clinical use according to the requirements of the Federal Food, Drug, and Cosmetic Act (the Act).
The guidance (1) provides brief background information, (2) makes recommendations to help you decide whether you should submit an NDA or an ANDA, (3) includes a description of the content and format needed in an NDA and an ANDA, and (4) provides boxed text that you can copy or cut and paste into your application. The content and format sections provide information required to submit an NDA or an ANDA for these PET drugs. Finally, we have developed sample formats for the chemistry sections and for the proposed labeling for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection as well as 356h sample forms. These formats are supplied as separate documents on FDA’s web site.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements apply. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Because this guidance discusses in great detail what must be submitted in an NDA (particularly a 505(b)(2) NDA) or an ANDA (505(j)), the guidance differs from most guidances in that it contains extensive mandatory language, especially in the Appendices. This mandatory language is used whenever the Act and/or FDA regulations require the submission of certain information. Unlike other documents in which mandatory language is accompanied by the related cite, to make the guidance more user friendly and less cumbersome, we do not cite each regulation each time we discuss a requirement.

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FDA Publish Rules on PET Drugs GMP

admin — Fri, 23 Sep 2011 11:54:16 +0000

FDA Publish Rules on PET Drugs GMP

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This guidance is intended to help small businesses better understand and comply with the regulations issued by the Food and Drug Administration (FDA) concerning current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The guidance addresses resources, procedures, and documentation for all PET drug production facilities. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements. FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
FDA’s guidance documents, including this guidance, should not be viewed as establishing legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Section 121(c)(1)(A) of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act) directed FDA to establish CGMP requirements for PET drugs. FDA established these requirements in 21 CFR part 212

As directed by Congress in the Modernization Act, to help in developing the PET CGMP regulations and this guidance, we closely examined the operations of many PET drug producers, including not-for-profit institutions and commercial manufacturers. Since the Modernization Act became law, significant changes have occurred in PET drug production in the United States. The number of PET drug production facilities has increased, as has the number of facilities where PET scans are performed. The business of PET drug production has changed as well. Historically, PET drugs were produced by academicians and researchers at PET drug production facilities located in universities and similar not-for-profit institutions. An academically oriented PET drug production facility usually produces small amounts (a few doses per day) of a few PET drugs for on-site patient use and a larger variety of PET drugs for clinical investigation and academic research.

An increasing number of PET drug production facilities are now operated by for-profit corporate entities that contract with academic and medical institutions (many of which have not-for-profit status) to manage the production of PET drugs at those institutions. Most of these PET drugs are administered on site, although often there is some distribution to other local or regional hospitals. In addition, a growing number of independent PET drug production facilities are not affiliated with any university or hospital. These for-profit, often contractually managed, and independently operated PET drug production facilities distribute PET drugs to significantly greater numbers of patients, sometimes hundreds of miles from the production site.

Our review of PET drug production has led to the conclusion that a PET drug producer’s status as either a not-for-profit or for-profit entity has little bearing on the quality of PET drugs that it produces and distributes for administration to patients, or on the methods, facilities, and controls that a PET drug production facility needs to ensure product quality. Instead, production and CGMP differences among PET drug producers are primarily a function of the size, scope, and complexity of their production operations. We have also found that implementing certain production standards and controls can ensure the production of quality PET drugs, regardless of differences among the various PET drug production facilities. The Agency believes that the welfare of a patient undergoing a PET scan should not depend on where a particular PET drug was produced.

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FDA Publish Guidance on PET Drug Applications

admin — Wed, 23 Mar 2011 14:09:36 +0000

FDA Publish Guidance on PET Drug Applications

This guidance is intended to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging for the indications cited in Section III (below). FDA approval of an NDA or ANDA will make it possible to market these PET drugs for clinical use according to the requirements of the Federal Food, Drug, and Cosmetic Act (the Act). This guidance revises the draft PET Drug Applications guidance published in March, 2000. It is being issued again as a draft for comment because FDA’s perspective has changed significantly since the draft was first published. However, because applications are to be submitted by December 12, 2011, it may be used to guide submissions while FDA obtains comments on it.
The guidance (1) provides brief background information, (2) makes recommendations to help you decide whether you should submit an NDA or an ANDA, (3) includes a description of the content and format needed in an NDA and an ANDA, and (4) provides boxed text that you can copy or cut and paste into your application. The content and format sections provide information required to submit an NDA or an ANDA for these PET drugs. Finally, we have developed sample formats for the chemistry sections and for the proposed labeling for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection as well as 356h sample forms. These formats are supplied as separate documents on FDA’s web site.

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FDA Publish Guidance on PET Drug NDAs and ANDAs

admin — Thu, 17 Feb 2011 13:51:05 +0000

FDA Publish Guidance on PET Drug NDAs and ANDAs

Full Text Here

On December 9, 2009, FDA issued a final current good manufacturing practice (CGMP) regulation for the production of positron emission tomography (PET) drugs. Under the requirements of section 121 of the Food and Drug Administration Modernization Act (FDAMA), within two years following this publication date, an NDA or ANDA must be submitted for any PET drug marketed for clinical use in the United States.
This guidance is intended to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging for the indications cited in Section III (below). FDA approval of an NDA or ANDA will make it possible to market these PET drugs for clinical use according to the requirements of the Federal Food, Drug, and Cosmetic Act (the Act).3 This guidance revises the draft PET Drug Applications guidance published in March, 2000. It is being issued again as a draft for comment because FDA’s perspective has changed significantly since the draft was first published. However, because applications are to be submitted by December 12, 2011, it may be used to guide submissions while FDA obtains comments on it.
The guidance (1) provides brief background information, (2) makes recommendations to help you decide whether you should submit an NDA or an ANDA, (3) includes a description of the content and format needed in an NDA and an ANDA, and (4) provides boxed text that you can copy or cut and paste into your application. The content and format sections provide information required to submit an NDA or an ANDA for these PET drugs. Finally, we have developed sample formats for the chemistry sections and for the proposed labeling for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection as well as 356h sample forms. These formats are supplied as separate documents on FDA’s web site.4
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements apply. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Because this guidance discusses in great detail what must be submitted in an NDA (particularly a 505(b)(2) NDA) or a 505(j) ANDA, the guidance differs from most guidances in that it contains extensive mandatory language, especially in the Appendices. This mandatory language is used whenever the Act and/or FDA regulations require the submission of certain information. Unlike other documents in which mandatory language is accompanied by the related cite, to make the guidance more user friendly and less cumbersome, we do not cite each regulation each time we discuss a requirement.

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Drug Regulators, FDA, CDER, Publish Guidance on PET Drugs Current Good Manufacturing Practice (CGMP)

admin — Wed, 30 Dec 2009 09:28:56 +0000

Drug Regulators, FDA, CDER, Publish Guidance on PET Drugs Current Good Manufacturing Practice (CGMP).

Full Text Here

This guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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