Latest Edition of DIA's Content Currents is available (April 26, 2013)

DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.


EDITION PUBLISHED: APRIL 26, 2013


SECTION 1: FDA GUIDANCES
April 23, FDA announced the availability of a draft guidance document for industry entitled, “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” This draft guidance is intended to aid prescription drug and biologic manufacturers in minimizing medication errors by focusing on safety aspects of the container label and carton labeling design. The 60 day comment period will close June 22, 2013. [Draft Guidance] (FDA.gov)

April 23, FDA announced the availability of a draft guidance document entitled, “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.’” This draft guidance is intended to aid sponsors in determining the potential toxicity of medical devices contacting the skin, clarify the Office of Device Evaluation General Program Memorandum #G95-1, and replace the memorandum when made final. [Draft Guidance] [FR Notice]

April 25, FDA announced the availability of a final guidance document entitled, “Assay Migration Studies for In Vitro Diagnostic Devices.” This guidance document is intended to provide a least burdensome approach to earn FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when an already approved assay is transitioning to a new system. [Guidance]

April 25, FDA also announced the availability of a final guidance document for industry entitled, “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance document is intended to aid sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) by informing them of the type of data that should be submitted to support the application. [Guidance] Note: the link appears to be temporarily unavailable as of 4/25/13. (FDA.gov)


For complete update, please visit http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z


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DIA's Content Currents | APRIL 12, 2013

DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.




EDITION PUBLISHED: APRIL 12, 2013

SECTION 1: FDA GUIDANCES
SECTION 2: FDA NOTES & RELATED NEWS
SECTION 3: AGENCY AND ADVISORY COMMITTEE MEETINGS
SECTION 4: OTHER REGULATORY AUTHORITIES & ORGANIZATIONS
SECTION 5: COMPLIANCE & LEGAL NEWS


SECTION 1: FDA GUIDANCES

April 12, FDA announced the availability of a draft guidance document entitled, “M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” This draft guidance is intended to provide recommendations and a framework that can be applied for the identification, categorization, qualification, and control of mutagenic impurities. [Draft Guidance] (FDA.gov) This document reached step 2 of the ICH process in February 2013, meaning that it was sent simultaneously to each of the ICH regions for internal and external consultation according to their regional procedures.

April 11, FDA announced the availability of a final guidance document entitled, “Medical Device Classification Product Codes.” This guidance is intended to describe how FDA uses product codes to regulate and track medical devices. [FR Notice]

April 10, FDA announced the availability of a final guidance document entitled, “Self-Selection Studies for Nonprescription Drug Products.” This guidance provides recommendations to industry on the study design, methodology and analyses of self-selection studies. Self-selection studies are used by regulators to determine whether a consumer can reasonably be expected to select an OTC product for an appropriate purpose and follow the labeling such that it is used appropriately. [Guidance] (FDA.gov)

April 9, FDA announced the availability of a draft guidance document entitled, “Molecular Diagnostic Instruments with Combined Functions.” This draft guidance advises industry and agency staff members on the type of information that should be included in a submission for molecular diagnostic instruments that have both device and non-device functions. [FR Notice]

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Pharmaceutical firms developed no major OTC drugs since 2000

SEOUL, April 17 (Yonhap) -- South Korean pharmaceutical companies have not produced major over-the-counter drugs since 2000, an industry association said Wednesday, as they focused on the development of profitable specialized drugs.

A total of 25 OTC drugs, whose separate annual sales topped 10 billion won (US$ 8.9 million) last year, were introduced before 2000 when the government mandated the separation of OTC medicine and prescription medicine, according to Korea Pharmaceutical Manufacturers Association.

The top 10 OTC drugs by sales volume include drugs with household names such as the popular energy drink "Bacchus," and they all hit the market before 2000, the association said.

The association also said only two out of 68 OTC drugs -- whose annual sales exceeded 5 billion won -- were produced since 2000, though the two medicines are made by foreign pharmaceutical companies.

Pharmaceutical firms developed no major OCT drugs since 2000



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Importance of Development Strategies for Life Cycle Management of Safe and Effective Medical Products -> 9th DIA Japan Annual Meeting

Don’t Miss this Highly Anticipated Event and Register Today. Informative tutorials, networking with colleagues and informative exhibits, impressive keynote speakers, and registration savings- all crucial elements to a successful meeting. Find them all at the 9th DIA Japan Annual Meeting, with focus on creating new solutions to the life cycle management of safe and effective medical products.   Online Registration     Read More UPCOMING EVENTS Conference Keynote Speakers and Tutorials Keynote Speaker 1: Peter Bachmann, DrSc European and International Affairs Member of the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) on the Latest Regulatory Environment in EU - from Development to Post-Marketing. Keynote Speech 2: Takao Yamori, PhD Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA) to discuss the New Drug Development of Japan Origin through Industry-Academia Collaboration. Tutorials: Tutorial 1: Company Core Data Sheets Prepared by Western Companies Tutorial 2: Roundtable Discussion: What are Preferable Skill Sets in Clinical Development Tutorial 3: Group Work: Action Learning for Six Sig Tutorial 4: Risk Management Plan - Standard (As of 10/30/2012) Tutorial 5: Leadership and Philosophy: Best Practice Tutorial 6: Basic Understanding of Bioequivalence   Online Registration     Read More

India Pushes To End Sale Of Branded Drugs, by Ed Silverman

The drug controller of India wants to prohibit medicines from being sold under brand names in a bid to accelerate the sale of lower-cost generics. In fact, states have been ordered to stop issuing licenses for the manufacture or sale of drugs under brand names, The Economic Times reports.

Under the plan, all drugmakers applying for a license to market or manufacture fixed dose combination drugs will have to submit the generic name and not the brand names. The move comes shortly after a parliamentary committee issued a report that also strongly opposed issuing licenses that use brand names, the paper writes.

“We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public,” Drugs Controller GN Singh tells the paper.

for complete article:  India Pushes To End Sale Of Branded Drugs

Fake Internet-Sold Medicine Becoming Public Health Threat.

The Chicago Tribune (10/16) reports that the FDA in "recent years has confiscated millions of dollars worth of counterfeit and other illegal medicine" sold online. The agency, in "partnership with international regulatory, customs and law enforcement agencies from 100 countries, shut down thousands of Internet pharmacies selling illegal drugs and seized about $10.5 million worth of pharmaceuticals during a weeklong crackdown on counterfeit and unapproved medications that began in late September. But such enforcement action isn't nearly enough to stop the proliferation of phony medicine." The FDA's Center for Drug Evaluation and Research Office of Compliance Director Ilisa Bernstein said, "This is a drop in the bucket. ... We may have some impact on these 4,100 websites, but they can pop up days or weeks later using another URL and another way to deceive consumers."

 

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

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DIA/FDA: Revitalizing Productivity in Drug Development

DIA/FDA: Revitalizing Productivity in Drug Development October 23-24 | Bethesda, MD Explore Initiatives that Champion Research & Development Productivity Review the status quo of the pharmaceutical industry and explore the initiatives that champion the continued revitalization of R&D productivity in drug development. This two-day conference will provide a forum for industry, regulators, and academia to come together to discuss challenges and opportunities, share visions, experiences, and lessons learned, as well as successes and failures in the challenging journey of drug development.   Keynote Speakers: Keynote Address I - Revitalizing R&D: What Could We Be Doing Differently? Robert J. Temple, MD, Deputy Center Director for Clinical Science, CDER, FDA   Keynote Address II - An Overview of the Future for Drug Development Under the New Imperatives Delivered by Both Commercial and Regulatory Pressures Stephen A. Arlington, PhD, Partner, Global Pharmaceutical and Life Sciences, Advisory Services Leader, PricewaterhouseCoopers LLP   Keynote Address III - How Do We Revitalize R&D in New Drug Development? Frank W. Rockhold, PhD, Senior Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline   Keynote Address IV - Collaborative Approaches to Advancing Clinical Development Charles G. Beever, MBA, Vice President, Booz and Company    Program Overview | Register Now

Developing World Health Partnerships Directory

Developing World Health Partnerships Directory reflects pharmaceutical industry’s and partners’ commitment to improving health in developing countries

 

Developing World Health Parntnerships Directory

Directory highlights commitment of the research-based pharmaceutical industry and partners to improve health in the developing world through 220 partnerships operating in more than 160 countries

 

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) published the 2012 update to its Developing World Health Partnerships Directory today. Now totaling 220 and reaching people in more than 160 countries, these health partnerships highlight the commitment of research-based pharmaceutical industry and its many partners including governments, intergovernmental organizations, nongovernmental organizations, private sector companies and universities to improve health around the world.

The launch of this directory coincides with the release of an independent review of the contributions these health partnerships' make to the health of people in low- and middle-income countries.

 

for complete article click below:

http://globalhealthprogress.org/developing-world-health-partnerships-directory-reflects-pharmaceutical-industry%E2%80%99s-and-partners%E2%80%99

FDA & Compounders: More Oversight Needed?

FDA & Compounders: More Oversight Needed?

from Pharmalot by Ed Silverman

Over the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin pose a safety risk (read here and here).

In another, KV Pharmaceutical caused a huge ruckus by initially charging $1,500 for its Makena premature birth drug and trying to use its FDA approval under the Orphan Drug Act to prevent compounding pharmacies, which charged a fraction of the price, from competing. The move outraged physicians, among others, who maintained the compounded versions were safe and kept a lid on rising healthcare costs.

Now, an outbreak of meningitis that has been traced to a compounding pharmacy in Massachusetts has, once again, placed compounding in the spotlight, and renewed debate about the extent to which oversight is sufficient. The outbreak, which has left five people dead and another 30 in various stages of illness across six states, appears to have been caused by a compounded steroid drug contaminated by a fungus.

for full article:
FDA & Compounders: More Oversight Needed?

Innovative Strategies for Individualized Health Care - November 1-4 Hyderabad

. Innovative Strategies for Individualized Health Care KEYNOTE SPEAKER Paul Huckle Senior Vice President Global Regulatory Affairs GlaxoSmithKline DIA India’s 7th Annual Conference: "Discovery Through Commercialization - Innovative Strategies for Individualized Health Care" is your only chance this year to interact and network with the largest gathering of International and Indian Regulators and Pharma professionals in India. This year at Hyderabad International Convention Centre (HICC), Hyderabad, this conference and exhibition will bring together over 400 of your key past, present and future patrons. There are over 100 international and Indian industry leaders who will present and discuss pertinent and relevant issues in 25 key sessions on topics related to Drug Discovery, Development, Manufacturing, Commercialization, Regulatory, Ethical, Social, Legal, Technology & Standards, Lean Strategy, Outsourcing Strategy, Pharmacovigilance and Therapeutics. For more information please click here to view the conference brochure or contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798.  Read More Participant Profile of Last Year's Conference Attendees - - - - - - - - - - - - - - - - - Program Highlights Discovery: Bioinformatics, Next Gen Sequencing, Lead optimization – the need for speed Development: Barriers and drivers relevant to clinical development across clinical operations, data management, biostatistics, programming, and medical writing, highlighting systems biology paradigm (e.g. pharmacogenomics, metabolomics) and innovative developmental approaches (e.g. chronotherapeutics, microdosing) Manufacturing: Flexible solutions to adapt to the evolving global regulatory scenario and quality standards Commercialization: Health economics and outcomes research driving product and pricing strategy, patient access, payor challenges, Go-to-investors and financial/partnering strategies for product development Regulatory, ethical, social and legal issues: Data privacy and consent issues in the evolving technologies related to personalized medicine Technology and Standards: Technology – SOA, the Cloud and the future, Data and Semantic Interoperability Technology, GRC (Governance, Regulation and Compliance) all focused on Personalized Medicine.  Lean strategy: The application of Lean in pharmacovigilance, medical writing, clinical operations and site performance. Driving the critical path. The conference will address the strategy for drug discovery and clinical development pipeline and faster time to market in the era of blockbuster patient expiries and issues of integrating and streamlining data flows across the entire life cycle of the molecule, and the standardization and rigor that needs to be implemented. It will also stress upon the ethical, legal, social and regulatory and financial and investments challenges impacting all of the above and how processes and technology will need to be upgraded to support the same. To know more contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798.  Read More Exhibit Details With over 9500 square feet of area the exhibition this year hosted at Hyderabad International Convention Centre (HICC), will help you connect with over 400 patrons. As an exhibitor you will be entitled to: Two complimentary conference passes Two complimentary exhibit booth attendee passes Pre-fitted shell scheme booth structure Fascia board with 25 character company name One electrical connection Three spotlights One table Two chairs One wastebasket Carpet Exhibit Fee: 3m x 2m booth space - INR 168,540/- (inclusive of taxes) Please click here to view the Exhibit Layout and Booking Form. For more details contact Manoj.Trivedi@diaindia.org  or call +91.98.1977.7493.  Read More Email Preferences    |    My DIA    |    Forward to a Friend    |

Flexible Manufacturing Solutions To Adapt To The Evolving Industry Scenario - Hyderabad, India

The 7th Annual Conference offers attendees a numbers of sessions specifically focusing on catering to manufacturing. To help the manufacturing industry DIA is offering a special 2 day registration fee. This can be availed by others as well. Details of these sessions are mentioned below.   Manufacturing - Session 12 - November 3, 2012  This session chaired by SC Singhai, Vice President - Tech Transfer, Dr. Reddy’s will discuss Potent Product Process and Facility Design by SC Singhai,Vice President - Tech Transfer, Dr. Reddy’s Quality Management Process in Faculty Development by Vinay Nayak, President, Alembic Pharmaceuticals World Class Manufacturing- A Challenge and Opportunity for the Indian Pharma Industry by Pushpinder Bindra, CEO, Zenith and Beyond Case Study: Integration of Patient Needs, and Quality Requirements in Recent Times has Enforced Application of “Quality by Design (QbD)” and “Process Analytical Technology (PAT)” to development of Therapeutic Vaccines by Nicolas Cappuccino, Global Head, Quality,  Dr. Reddy’s   Register Online      Read More Manufacturing - Session 15 - November 3, 2012 This session chaired by Subir Basak, President, Jubilant Biosys will discuss Pharmacogenomics for Personalized Medicine: Optimizing use of Drug and Drug Combinations to Improve Patient Outcome by Jugnu Jain, Director, Saarum Siences Quality Control, a Necessary Paradigm when “Leaning Out” Operations, as Pharmaceuticals Shift from the Blockbuster Model to Personalized Gene Therapies and Gene-specific Small-molecule Treatments by Swapnil Baghel, Quality Lead, Biocon BioManufacturing in India by Subir Basak, President, Jubilant Biosys   Register Online      Read More 7th Annual Conference Registration Fees Reduced Registration fees at the 7th Annual Conference have been reduced by nearly 20% to as low as Rs. 9,000 + taxes to help the industry participate in large numbers and gain immensely through this unique networking opportunity. Click here to view the conference program with over 75 International & India industry leaders. For more information and group registrations please contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798. Follow us and tweet on the 7th Annual Conference with #DIAIndiaAM2012   Register Online      Read More Email Preferences    |    My DIA    |    Forward to a Friend    |

第10回DIA日本年会を 11月6日～8日

11月6日～8日、東京有明のTFTホールにて開催決定 第10回DIA日本年会を、来る11月6日（水）～8日（金）、東京都江東区有明のTFT東京ファッションタウンビルにて開催します。今年のテーマは「日本発の創薬革命　～ 革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割 ～」。昨年に引き続き、3日間6トラックで臨床 / 薬事 / 統計 / 安全性 / プロジェクトマネジメント / データマネジメント / CMC / メディカルライティング / シックシグマ / HTA (Health Technology Assessment) / 患者会等の各領域に関連した、数多くのセッションを企画中です。 プログラムの詳細は8月中に発表予定。

*************************************


第9回 DIA日本年会 (第九DIA日本年会プログラムの日本語版については、29ページを参照してください。)
市販後を見据えた開発戦略の重要性
〜 患者のベネフィットのために開発段階から
　 できることは何か 〜
2012年11月19日(月)～21日(水)
都市センターホテル　

http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=29909&EventType=Meeting

フルパッケージ（フルプログラムと2チュートリアル）のための特別な価格設定を活用してください。詳細については、登録フォームを表示し、FAXにて登録してください。

 

後援予定：厚生労働省/独立行政法人医薬品医療機器総合機構/

　　　　 日本製薬工業協会

卓上展示申込受付中

詳細については、下記までお問い合わせください。

一般社団法人ディー・アイ・エー・ジャパン

〒

106-0041 東京都港区麻布台1-11-10 日総第22ビル7F

Tel: 

03-5575-2130

Fax:

03-3583-1200

email: DIAJapan@diajapan.org


ここ数年、日本では製薬企業と規制当局がドラックラグ解消を目標に開発・審
査スピードの短縮に取り組み、着実な成果を挙げてきています。しかし、患者
さんの手元に早く薬剤が届きさえすればよいのではなく、開発期間や審査期間
が短縮されても、限られたデータから薬剤のベネフィット・リスクを最大限予測
し、発売前に十分な安全対策を講じなければならないことは言うまでもありませ
ん。医薬品は「両刃の剣」とも例えられるように、安全性の懸念をすべて払拭す
ることはできませんが、副作用による重篤な障害などをできる限り防ぐため、開
発・審査スピードが増している今こそ、市販後を見据えた開発戦略に基づき多角
的視点からの分析や振り返りをしなければならない時期に来ていると思います。
2012年は1)医薬品リスク管理計画（リスクマネジメントプラン：RMP）に関する
薬事法の改正、2）ICH E2E 改正に基づく定期的ベネフィット・リスクのレビュー
（PBRER）、3)添付文書についての法的位置付けに関する議論など、市販後の
リスク/ベネフィットに関する話題が尽きない１年です。時代が変わり開発戦略
が多様化しても、患者さんを第一に、ベネフィットがある製品を開発、審査、そし
て販売していかなければなりません。製薬企業等においては開発早期段階か
らの組織横断的な連携がより重要となり、また医療現場・開発メーカー・当局の
間の協働は透明性と効率化がますます求められるでしょう。既にPMDAではリ
スクマネージャーという役職が新設され、治験相談の段階から審査メンバーの
一員として活躍しています。
本年会では、安全性に関する話題を軸に患者さんへのベネフィットをキーワード
に取り挙げます。また、開発の国際化がますます推進されている状況を鑑み、
幅広い専門分野での議論も必要であると考え、CMCやプロジェクトマネジメント
をはじめ、過去の日本年会では取り挙げてこなかったトピックスも取り挙げます。
さらに、今年はUSでのDIA Annual MeetingやDIA EUROで御馴染みのTutorial
やStudent Sessionを日本でも初めて導入することにしました。
医薬品等に関する開発・審査の基礎から最新情報までを幅広く得るには大変
良い機会です。ご興味やご担当業務にあうセッション・トピックスが多数見つか
ると思いますので、是非ご期待ください。多くの方のご参加をお待ちしています。


プログラム委員長
第一三共株式会社
廣川 和憲

プログラム副委員長
ノバルティス ファーマ株式会社
西野 潤一

プログラム委員
国立がん研究センター東病院
土井 俊彦

東京大学大学院 薬学系研究科
草間 真紀子

ファイザー株式会社
松井 理恵

第一三共株式会社
松岡 洋明

ファイザー株式会社
長山 敏

日本イーライリリー株式会社
多喜田 保志

MSD株式会社
田中 義信

第一三共株式会社
塚本 淳

独立行政法人 医薬品医療機器総合機構
宇山 佳明

メルクセローノ株式会社
安田 倫栄

株式会社スーザック
横堀 真