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ANDA litigation : strategies and tactics for pharmaceutical patent litigators / / Kenneth L. Dorsney, editor-in-chief
| ANDA litigation : strategies and tactics for pharmaceutical patent litigators / / Kenneth L. Dorsney, editor-in-chief |
| Pubbl/distr/stampa | American Bar Association |
| Disciplina | 346.7304/86 |
| Soggetto topico |
Biotechnology - United States - Patents
Drugs - United States - Patents Patent suits - United States Pharmacy - Law and legislation - United States |
| Soggetto non controllato | Abbreviated New Drug Application |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The statutory and regulatory scheme -- The drug approval process--an overview -- Notice and prefiling considerations -- The litigation timeline -- Initiating litigation -- Use of reissue proceedings in Hatch-Waxman litigation -- Inter partes review in ANDA litigation -- Examining subject-matter jurisdiction over declaratory judgment claims filed in combination with patent infringement claims under section 271(e)(2)(a) -- Responding to the complaint -- Discovery -- Experts -- Claim construction -- Summary judgment -- Remedies -- Settlement -- Antitrust -- Pretrial preparation -- Trial -- Posttrial -- Appeals to the Court of Appeals for the Federal Circuit -- Hatch-Waxman practice in the Supreme Court of the United States -- Managing an ANDA litigation -- Pharmaceutical regulation and litigation in foreign countries. |
| Altri titoli varianti | ANDA litigation |
| Record Nr. | UNINA-9910671107803321 |
| American Bar Association | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Discussion draft of the Food and Drug Administration Globalization Act legislation [[electronic resource] ] : drug safety : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, May 1, 2008
| Discussion draft of the Food and Drug Administration Globalization Act legislation [[electronic resource] ] : drug safety : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, May 1, 2008 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
| Descrizione fisica | 1 online resource (vi, 238 pages) : illustrations, maps |
| Soggetto topico |
Drugs - Law and legislation - United States
Pharmacy - Law and legislation - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Discussion draft of the Food and Drug Administration Globalization Act legislation |
| Record Nr. | UNINA-9910699912803321 |
| Washington : , : U.S. G.P.O., , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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DXM Abuse Prevention Act of 2015 : report (to accompany H.R. 3250) (including cost estimate of the Congressional Budget Office)
| DXM Abuse Prevention Act of 2015 : report (to accompany H.R. 3250) (including cost estimate of the Congressional Budget Office) |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2016] |
| Descrizione fisica | 1 online resource (26 pages) |
| Collana | Report / 114th Congress, 2d session, House of Representatives |
| Soggetto topico |
Dextromethorphan - Law and legislation - United States
Drug abuse - Law and legislation - United States Pharmacy - Law and legislation - United States |
| Soggetto genere / forma | Legislative materials. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | DXM Abuse Prevention Act of 2015 |
| Record Nr. | UNINA-9910707376603321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2016] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg
| Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg |
| Autore | Strandberg Kenneth M. |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Boca Raton, Fla. : , : CRC Press, , 2012 |
| Descrizione fisica | 1 online resource (184 p.) |
| Disciplina | 344.7304/16 |
| Collana | Pharmacy Education Series |
| Soggetto topico |
Pharmacy technicians - Professional ethics - United States
Pharmacists - Legal status, laws, etc - United States Pharmacy - Law and legislation - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-429-24843-1
1-4398-9610-0 1-4398-5315-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Acknowledgments; Authors; The legal system in the United States; Chapter 2: History and development of current law; Chapter 3: Food, Drug, and Cosmetic Act of 1938; Chapter 4: Federal Controlled Substance Act of 1970; Chapter 5: Other pertinent federal legislation; Chapter 6: Ethics theory and application; appendix one: Addresses and websites of board of pharmacy executives; appendix two: Addresses and websites of pertinent pharmacy organizations; appendix three: List of accredited pharmacy technician programs; appendix four: Sample DEA forms
appendix five: Legal standing of pharmacy techniciansappendix six: Legal status of fax prescriptions; appendix seven: Legal status of electronic transmission of prescriptions; appendix eight: Who has prescribing authority; Back Cover |
| Record Nr. | UNINA-9910464078703321 |
Strandberg Kenneth M.
|
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| Boca Raton, Fla. : , : CRC Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg
| Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg |
| Autore | Strandberg Kenneth M. |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Boca Raton, Fla. : , : CRC Press, , 2012 |
| Descrizione fisica | 1 online resource (184 p.) |
| Disciplina | 344.7304/16 |
| Collana | Pharmacy Education Series |
| Soggetto topico |
Pharmacy technicians - Professional ethics - United States
Pharmacists - Legal status, laws, etc - United States Pharmacy - Law and legislation - United States |
| ISBN |
0-429-24843-1
1-4398-9610-0 1-4398-5315-0 |
| Classificazione | LAW093000MED071000MED072000 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Acknowledgments; Authors; The legal system in the United States; Chapter 2: History and development of current law; Chapter 3: Food, Drug, and Cosmetic Act of 1938; Chapter 4: Federal Controlled Substance Act of 1970; Chapter 5: Other pertinent federal legislation; Chapter 6: Ethics theory and application; appendix one: Addresses and websites of board of pharmacy executives; appendix two: Addresses and websites of pertinent pharmacy organizations; appendix three: List of accredited pharmacy technician programs; appendix four: Sample DEA forms
appendix five: Legal standing of pharmacy techniciansappendix six: Legal status of fax prescriptions; appendix seven: Legal status of electronic transmission of prescriptions; appendix eight: Who has prescribing authority; Back Cover |
| Record Nr. | UNINA-9910787962803321 |
|
Strandberg Kenneth M.
|
||
| Boca Raton, Fla. : , : CRC Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg
| Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg |
| Autore | Strandberg Kenneth M. |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Boca Raton, Fla. : , : CRC Press, , 2012 |
| Descrizione fisica | 1 online resource (184 p.) |
| Disciplina | 344.7304/16 |
| Collana | Pharmacy Education Series |
| Soggetto topico |
Pharmacy technicians - Professional ethics - United States
Pharmacists - Legal status, laws, etc - United States Pharmacy - Law and legislation - United States |
| ISBN |
0-429-24843-1
1-4398-9610-0 1-4398-5315-0 |
| Classificazione | LAW093000MED071000MED072000 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Acknowledgments; Authors; The legal system in the United States; Chapter 2: History and development of current law; Chapter 3: Food, Drug, and Cosmetic Act of 1938; Chapter 4: Federal Controlled Substance Act of 1970; Chapter 5: Other pertinent federal legislation; Chapter 6: Ethics theory and application; appendix one: Addresses and websites of board of pharmacy executives; appendix two: Addresses and websites of pertinent pharmacy organizations; appendix three: List of accredited pharmacy technician programs; appendix four: Sample DEA forms
appendix five: Legal standing of pharmacy techniciansappendix six: Legal status of fax prescriptions; appendix seven: Legal status of electronic transmission of prescriptions; appendix eight: Who has prescribing authority; Back Cover |
| Record Nr. | UNINA-9910800184803321 |
|
Strandberg Kenneth M.
|
||
| Boca Raton, Fla. : , : CRC Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg
| Essentials of law and ethics for pharmacy technicians / / Kenneth M. Strandberg |
| Autore | Strandberg Kenneth M. |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Boca Raton, Fla. : , : CRC Press, , 2012 |
| Descrizione fisica | 1 online resource (184 p.) |
| Disciplina | 344.7304/16 |
| Collana | Pharmacy Education Series |
| Soggetto topico |
Pharmacy technicians - Professional ethics - United States
Pharmacists - Legal status, laws, etc - United States Pharmacy - Law and legislation - United States |
| ISBN |
0-429-24843-1
1-4398-9610-0 1-4398-5315-0 |
| Classificazione | LAW093000MED071000MED072000 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Contents; Preface; Acknowledgments; Authors; The legal system in the United States; Chapter 2: History and development of current law; Chapter 3: Food, Drug, and Cosmetic Act of 1938; Chapter 4: Federal Controlled Substance Act of 1970; Chapter 5: Other pertinent federal legislation; Chapter 6: Ethics theory and application; appendix one: Addresses and websites of board of pharmacy executives; appendix two: Addresses and websites of pertinent pharmacy organizations; appendix three: List of accredited pharmacy technician programs; appendix four: Sample DEA forms
appendix five: Legal standing of pharmacy techniciansappendix six: Legal status of fax prescriptions; appendix seven: Legal status of electronic transmission of prescriptions; appendix eight: Who has prescribing authority; Back Cover |
| Record Nr. | UNINA-9910816542103321 |
|
Strandberg Kenneth M.
|
||
| Boca Raton, Fla. : , : CRC Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The Food and Drug Import Safety Act [[electronic resource] ] : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, on H.R. 3610, September 26, 2007
| The Food and Drug Import Safety Act [[electronic resource] ] : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, on H.R. 3610, September 26, 2007 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
| Descrizione fisica | vi, 214 pages : digital, PDF file |
| Soggetto topico |
Drugs - Purchasing - Government policy - United States
Pharmacy - Law and legislation - United States Imports - Law and legislation - United States User charges - Law and legislation - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Food and Drug Import Safety Act |
| Record Nr. | UNINA-9910697743703321 |
| Washington : , : U.S. G.P.O., , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010; and H.R. 5809, the Safe Drug Disposal Act of 2010 : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, second session, July 22, 2010
| H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010; and H.R. 5809, the Safe Drug Disposal Act of 2010 : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, second session, July 22, 2010 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2013 |
| Descrizione fisica | 1 online resource (v, 69 pages) |
| Soggetto topico |
Medication abuse - Law and legislation - United States
Drugs - Prescribing - Law and legislation - United States Pharmacy - Law and legislation - United States Refuse and refuse disposal - Law and legislation - United States Medical wastes - Law and legislation - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010; and H.R. 5809, the Safe Drug Disposal Act of 2010 |
| Record Nr. | UNINA-9910704540703321 |
| Washington : , : U.S. Government Printing Office, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Journal of GXP compliance
| Journal of GXP compliance |
| Pubbl/distr/stampa | Royal Palm Beach, FL, : Institute of Validation Technology |
| Disciplina | 353.9/97/097305 |
| Soggetto topico |
Pharmacy - Law and legislation - United States
Medical instruments and apparatus industry - Law and legislation - United States Food law and legislation - United States Pharmaceutical Preparations - standards Clinical Trials as Topic - standards Drug and Narcotic Control - legislation & jurisprudence Equipment and Supplies - standards Quality Control Food law and legislation Medical instruments and apparatus industry - Law and legislation Pharmacy - Law and legislation |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 2150-6590 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | GXP compliance |
| Record Nr. | UNISA-996209185003316 |
| Royal Palm Beach, FL, : Institute of Validation Technology | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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