Works matching DE "DRUG approval laws"

Results: 219

Pharmaceutical pricing conundrum: time to get rid of it?

Published in:

2018

By:

Garattini, Livio;
Padula, Anna

Publication type:

Editorial

Four years of early benefit assessment of new drugs in Germany: a qualitative study on methodological requirements for quality of life data.

Published in:

2017

By:

Blome, Christine;
Augustin, Matthias;
Metin, Hidayet;
Lohrberg, David

Publication type:

journal article

Patient access to pharmaceuticals: an international comparison.

Published in:

2007

By:

Cohen, Joshua;
Faden, Laura;
Predaris, Susan;
Young, Brian

Publication type:

journal article

Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.

Published in:

European Journal of Clinical Pharmacology, 2025, v. 81, n. 5, p. 605, doi. 10.1007/s00228-025-03822-w

By:

Sharma, Rohini;
Gulati, Anamika;
Chopra, Kanwaljit

Publication type:

Article

Quality, efficacy, safety—it is not enough!

Published in:

European Journal of Clinical Pharmacology, 2021, v. 77, n. 9, p. 1425, doi. 10.1007/s00228-021-03110-3

By:

Garattini, Silvio

Publication type:

Article

An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe.

Published in:

European Journal of Clinical Pharmacology, 2015, v. 71, n. 10, p. 1237, doi. 10.1007/s00228-015-1904-1

By:

Ebbers, Hans;
Langedijk, Joris;
Bouvy, Jacoline;
Hoekman, Jarno;
Boon, Wouter;
Jong, Jean;
Bruin, Marie

Publication type:

Article

Clinical pharmacology and regulatory consequences of GnRH analogues in prostate cancer.

Published in:

European Journal of Clinical Pharmacology, 2014, v. 70, n. 7, p. 791, doi. 10.1007/s00228-014-1682-1

By:

Eckstein, Niels;
Haas, Bodo

Publication type:

Article

A LEGAL CHALLENGE OF THE PRESCRIPTION DRUG USER FEE ACT.

Published in:

Journal of Law & Health, 2016, v. 29, n. 1, p. 85

By:

ZHUANG, JIMMY J.

Publication type:

Article

Oncology Drug Shortages—What We Have Versus What We Expect to Have? A Critical Scenario of Pakistan.

Published in:

Journal of Pharmacy Technology, 2019, v. 35, n. 1, p. 41, doi. 10.1177/8755122518810853

By:

Elahi, Ehsan;
Andleeb, Sidrah

Publication type:

Article

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval.

Published in:

2021

By:

Shahzad, Mahnum;
Naci, Huseyin;
Wagner, Anita K.

Publication type:

journal article

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019.

Published in:

2020

By:

Chen, Emerson Y.;
Haslam, Alyson;
Prasad, Vinay

Publication type:

journal article

Evidence of Efficacy and Human Right to Health.

Published in:

American Journal of Bioethics, 2012, v. 12, n. 6, p. 35, doi. 10.1080/15265161.2012.677619

By:

Edwards, SarahJ. L.;
Lignou, Sapfo;
Oduwo, Elizabeth

Publication type:

Article

Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.

Published in:

Journal of the Pediatric Infectious Diseases Society, 2024, v. 13, p. S93, doi. 10.1093/jpids/piae036

By:

Domachowske, Joseph B

Publication type:

Article

Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.

Published in:

2016

By:

Chin, William;
Joos, Angelika;
Chin, William Wei Lim

Publication type:

journal article

An Investigation in the Comparability of the Exposure and Recommended Dose of Selected Pfizer Drugs in East Asian Countries: Is Mutual Usage of Clinical Data Among East Asian Countries Feasible?

Published in:

Journal of Clinical Pharmacology, 2024, v. 64, n. 5, p. 609, doi. 10.1002/jcph.2394

By:

Wang, Diane D.;
Yu, Yanke;
Fukuhara, Kei;
Liu, Yuwang;
Park, So‐Young;
Parivar, Kourosh

Publication type:

Article

The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct.

Published in:

Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1475, doi. 10.1002/jcph.2151

By:

Moore, Kenneth T.;
Grundmann, Oliver;
Iwuchukwu, Otito;
Rakhmanina, Natella

Publication type:

Article

Preventing a New Tuskegee: Food and Drug Administration Oversight of Overseas Research Must Match That in the United States.

Published in:

Journal of Clinical Pharmacology, 2022, v. 62, n. 3, p. 434, doi. 10.1002/jcph.1976

By:

White, C. Michael;
White, Lyla R.

Publication type:

Article

Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020.

Published in:

2022

By:

Zhang, Audrey D.;
Puthumana, Jeremy;
Egilman, Alexander C.;
Schwartz, Jason L.;
Ross, Joseph S.

Publication type:

Letter

Learning from the Opioid Epidemic: Preventing the Next Healthcare Marketing Crisis.

Published in:

2021

By:

Uppal, Nishant;
Anderson, Timothy S.

Publication type:

Editorial

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.

Published in:

2021

By:

Egilman, Alexander;
Wallach, Joshua D.;
Puthumana, Jeremy;
Zhang, Audrey D.;
Schwartz, Jason L.;
Ross, Joseph S.

Publication type:

Letter

If Kindness Were a Drug, the FDA Would Approve It.

Published in:

2021

By:

Asch, Steven M.;
Atkins, Dale V.;
Walling, Anne

Publication type:

Editorial

THE DEMISE OF DRUG DESIGN LITIGATION: DEATH BY FEDERAL PREEMPTION.

Published in:

American University Law Review, 2018, v. 68, n. 1, p. 281

By:

TWERSKI, AARON D.

Publication type:

Article

CITIZEN PETITIONS: LONG, LATE-FILED, AND AT-LAST DENIED.

Published in:

American University Law Review, 2016, v. 66, n. 2, p. 305

By:

CARRIER, MICHAEL A.;
MINNITI, CARL

Publication type:

Article

Pediatric requirements in Europe stymie help for hemophilia.

Published in:

Nature Medicine, 2014, v. 20, n. 2, p. 117, doi. 10.1038/nm0214-117

By:

Peyvandi, Flora;
Rosendaal, Frits R;
O'Mahony, Brian;
Mannuccio Mannucci, Pier

Publication type:

Article

First 'breakthrough' drugs designated, but dilution worries linger.

Published in:

Nature Medicine, 2013, v. 19, n. 2, p. 116, doi. 10.1038/nm0213-116

By:

Dolgin, Elie

Publication type:

Article

Congress vouches for priority review of childhood disease.

Published in:

Nature Medicine, 2012, v. 18, n. 2, p. 181, doi. 10.1038/nm0212-181

By:

Palmer, Roxanne

Publication type:

Article

Combination products neglected by FDA device evaluation.

Published in:

Nature Medicine, 2011, v. 17, n. 9, p. 1024, doi. 10.1038/nm0911-1024a

By:

Waters, Hannah

Publication type:

Article

French law to make conflict of interest disclosure mandatory.

Published in:

Nature Medicine, 2011, v. 17, n. 9, p. 1026, doi. 10.1038/nm0911-1026a

By:

Louët, Sabine

Publication type:

Article

Overwhelmed drug regulators seek cure in cooperation.

Published in:

Nature Medicine, 2011, v. 17, n. 7, p. 753, doi. 10.1038/nm0711-753

By:

Laursen, Lucas

Publication type:

Article

Biosimilars legislation awakens data exclusivity debate.

Published in:

Nature Medicine, 2009, v. 15, n. 11, p. 1242, doi. 10.1038/nm1109-1242a

By:

Hutson, Stu

Publication type:

Article

Looking for Venue in the Patently Right Places: A Parallel Study of the VENUE Act and Venue in ANDA Litigation.

Published in:

San Diego Law Review, 2018, v. 55, n. 1, p. 183

By:

MENGKE XING

Publication type:

Article

Setbacks in Regulatory Data Protection Confront Innovative Drug Developers in the Russian Federation.

Published in:

International Lawyer, 2018, v. 51, n. 2, p. 171

By:

MCDONALD, BRUCE;
UGRYUMOV, VLADISLAV;
KOLESNIKOV, DENIS

Publication type:

Article

PHARMACEUTICAL PATENT LITIGATION SETTLEMENTS: BALANCING PATENT & ANTITRUST POLICY THROUGH INSTITUTIONAL CHOICE.

Published in:

Michigan Telecommunications & Technology Law Review, 2011, v. 17, n. 2, p. 417

By:

Cook, Timothy A.

Publication type:

Article

Putting the "good" into Good Clinical Practice.

Published in:

2021

By:

Symons, Tanya;
Webb, Steve;
Zalcberg, John R

Publication type:

journal article

The role of the citizen’s petition amendment to the FDCA in preventing delays to generic approvals.

Published in:

Journal of Generic Medicines, 2013, v. 10, n. 2, p. 131, doi. 10.1177/1741134313494205

By:

Roylance, Stephen M

Publication type:

Article

Patent dispute resolution under the Biologics Price Competition and Innovation Act.

Published in:

Journal of Generic Medicines, 2012, v. 9, n. 3, p. 118, doi. 10.1177/1741134312454258

By:

Munck, Suzanne Drennon

Publication type:

Article

Prescribing "Off-Label": What Should a Physician Disclose?

Published in:

AMA Journal of Ethics, 2016, v. 18, n. 6, p. 587, doi. 10.1001/journalofethics.2016.18.6.ecas3-1606

By:

Furey, Katrina;
Wilkins, Kirsten

Publication type:

Article

BIOLOGICS IN THE PRACTICE OF LAW.

Published in:

2016

By:

KELLY, LINDSAY

Publication type:

Essay

The use of mechanistic evidence in drug approval.

Published in:

Journal of Evaluation in Clinical Practice, 2018, v. 24, n. 5, p. 1166, doi. 10.1111/jep.12960

By:

Aronson, Jeffrey K.;
La Caze, Adam;
Kelly, Michael P.;
Parkkinen, Veli‐Pekka;
Williamson, Jon

Publication type:

Article

The Waiting Game – How Cooperation Between Public and Private Hospitals Can Help Reduce Waiting Lists.

Published in:

Health Care Management Science, 2022, v. 25, n. 1, p. 100, doi. 10.1007/s10729-021-09577-x

By:

Acuna, Jorge A.;
Zayas-Castro, José L.;
Feijoo, Felipe;
Sankaranarayanan, Sriram;
Martinez, Rodrigo;
Martinez, Diego A.

Publication type:

Article

3D Printing Medical Devices at the Point of Care -- FDA Invites Feedback.

Published in:

Journal of Health Care Compliance, 2021, v. 23, n. 6, p. 19

By:

Boubker, Jessa;
Faget, Kyle

Publication type:

Article

CARA and the FDA: The Call to Convene and the Charge to Clarify.

Published in:

University of Memphis Law Review, 2018, v. 48, n. 4, p. 1425

By:

BARENIE, RACHEL ELIZABETH

Publication type:

Article

SUBSTANTIALLY UNEQUIVALENT: REFORMING FDA REGULATION OF MEDICAL DEVICES.

Published in:

University of Illinois Law Review, 2014, v. 2014, n. 4, p. 1363

By:

LENNOX, KYLE

Publication type:

Article

Regulatory considerations on endpoints in ovarian cancer drug development.

Published in:

2017

By:

Balasubramaniam, Sanjeeve;
Kim, Geoffrey S.;
McKee, Amy E.;
Pazdur, Richard

Publication type:

journal article

AN EXAMINATION OF THE RIGHT TO TRY ACT OF 2017 AND INDUSTRY'S POTENTIAL PATH MOVING FORWARD.

Published in:

Southern California Law Review, 2020, v. 93, n. 2, p. 331

By:

ZAICH, SYLVIA

Publication type:

Article

REMS: Time to reevaluate.

Published in:

American Journal of Health-System Pharmacy, 2024, v. 81, n. 9, p. e206, doi. 10.1093/ajhp/zxad338

By:

Daujatas, Deanna M;
Eischen, Edward;
Quinn, Andrea L

Publication type:

Article

Therapeutic innovation: Impact of precision medicine.

Published in:

American Journal of Health-System Pharmacy, 2018, v. 75, n. 2, p. 27

By:

Kolesar, Jill;
Crismon, M. Lynn

Publication type:

Article

News.

Published in:: Chemistry & Industry, 2012, v. 76, n. 6, p. 6, doi. 10.1002/cind.7606_3.x
Publication type:: Article

New, but not always better?

Published in:: 2012
Publication type:: Opinion

A NEW PRESCRIPTION TO BALANCE SECRECY AND DISCLOSURE IN DRUG-APPROVAL PROCESSES.

Published in:

University of Michigan Journal of Law Reform, 2012, v. 46, n. 1, p. 135, doi. 10.36646/mjlr.46.1.new

By:

Beckhaus, Gerrit M.

Publication type:

Article