Works matching DE "DRUG approval laws"

Results: 219

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.

Published in:

Pan American Journal of Public Health / Revista Panamericana de Salud Pública, 2021, v. 45, p. 1, doi. 10.26633/RPSP.2021.10

By:

Durán, Carlos E.;
Cañás, Martín;
Urtasun, Martín A.;
Elseviers, Monique;
Andia, Tatiana;
Vander Stichele, Robert;
Christiaens, Thierry

Publication type:

Article

Leveraging Design Thinking for Pharmaceutical Digital Marketing.

Published in:

Asian Journal of Business Research, 2021, v. 11, n. 1, p. 1, doi. 10.14707/ajbr.210102

By:

Ngamvichaikit, Anothai

Publication type:

Article

Food and Drug Administration v. Alliance for Hippocratic Medicine: How Conscience Protections Preserved Mifepristone Access.

Published in:

Hastings Center Report, 2025, v. 55, n. 2, p. 6, doi. 10.1002/hast.4974

By:

Dresser, Rebecca

Publication type:

Article

Big Mistake: Knowing and Doing Better in Patient Engagement.

Published in:

Hastings Center Report, 2023, v. 53, n. 6, p. 2, doi. 10.1002/hast.1537

By:

Lynch, Holly Fernandez

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

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

Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?

Published in:

American Journal of Public Health, 2017, v. 107, n. 11, p. 1752, doi. 10.2105/AJPH.2017.304093

By:

Zuckerman, Diana M.

Publication type:

Article

House passes 12st Century Cures Act.

Published in:

Ocular Surgery News, 2015, v. 33, n. 15, p. 34

By:

Hasson, Matt

Publication type:

Article

NEWS FROM THE OPHTHALMOLOGY INNOVATION SUMMIT.

Published in:: Ocular Surgery News, 2011, v. 29, n. 22, p. 43
Publication type:: Article

Commentary: Evidence-empty regulations hinder patient care.

Published in:

Ocular Surgery News, 2011, v. 29, n. 12, p. 32

By:

Gayton, Johnny L.;
Schneider, Henry

Publication type:

Article

SPARSE PATENT PROTECTION FOR RESEARCH TOOLS: EXPANSION OF THE SAFE HARBOR HAS CHANGED THE RULES.

Published in:

Emory Law Journal, 2014, v. 63, n. 3, p. 749

By:

JONES, ROBERT A.

Publication type:

Article

Dexilant not an ‘innovative drug’ under Canada's Food and Drug Regulations.

Published in:

Journal of Intellectual Property Law & Practice, 2013, v. 8, n. 7, p. 518, doi. 10.1093/jiplp/jpt067

By:

Crowne, Emir;
Moazzam, Lida

Publication type:

Article

Challenges in orphan drug development and regulatory policy in China.

Published in:

2017

By:

Cheng, Alice;
Zhi Xie;
Xie, Zhi

Publication type:

journal 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

A paradigm shift in evaluation of new medications for older adults—A mandate has arrived!

Published in:

Journal of the American Geriatrics Society, 2024, v. 72, n. 9, p. 2892, doi. 10.1111/jgs.19028

By:

Schwartz, Janice B.

Publication type:

Article

Addendum. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes—2023. Diabetes Care 2023;46(Suppl. 1):S41–S48.

Published in:

2023

By:

ElSayed, Nuha A.;
Aleppo, Grazia;
Aroda, Vanita R.;
Bannuru, Raveendhara R.;
Brown, Florence M.;
Bruemmer, Dennis;
Collins, Billy S.;
Hilliard, Marisa E.;
Isaacs, Diana;
Johnson, Eric L.;
Kahan, Scott;
Khunti, Kamlesh;
Leon, Jose;
Lyons, Sarah K.;
Perry, Mary Lou;
Prahalad, Priya;
Pratley, Richard E.;
Seley, Jane Jeffrie;
Stanton, Robert C.;
Gabbay, Robert A.

Publication type:

Correction Notice

Addendum. 2. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes—2023. Diabetes Care 2023;46(Suppl. 1):S19–S40.

Published in:

2023

By:

ElSayed, Nuha A.;
Aleppo, Grazia;
Aroda, Vanita R.;
Bannuru, Raveendhara R.;
Brown, Florence M.;
Bruemmer, Dennis;
Collins, Billy S.;
Hilliard, Marisa E.;
Isaacs, Diana;
Johnson, Eric L.;
Kahan, Scott;
Khunti, Kamlesh;
Leon, Jose;
Lyons, Sarah K.;
Perry, Mary Lou;
Prahalad, Priya;
Pratley, Richard E.;
Seley, Jane Jeffrie;
Stanton, Robert C.;
Gabbay, Robert A.

Publication type:

Correction Notice

Alternate approaches for pediatric type 1 diabetes drug development and potential regulatory approval: a perspective.

Published in:

2015

By:

Turner, J. Rick;
Close, Kelly L.;
Fleming, G. Alexander;
Wherrett, Diane K.;
DiMeglio, Linda A.

Publication type:

journal 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

Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption.

Published in:

2022

By:

Hair, John;
Maryon, Thomas;
Lieneck, Cristian

Publication type:

Literature Review

Access to Mifepristone Still in Legal Limbo.

Published in:: Contraceptive Technology Update, 2023, v. 44, n. 4, p. 1
Publication type:: Article

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

What Is the Purpose of the Orphan Drug Act?

Published in:

2017

By:

Herder, Matthew

Publication type:

journal article

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.

Published in:

Journal of Law, Medicine & Ethics, 2024, v. 52, n. 4, p. 940, doi. 10.1017/jme.2024.171

By:

Scholte, Mirre;
Bendicksen, Liam;
Grimm, Sabine E.;
Abu-Zahra, Teebah;
Pauly, Bianca;
Joore, Manuela;
Kesselheim, Aaron S.

Publication type:

Article

Patent Claim Scope and Biosimilar Competition in the US and EU.

Published in:

Journal of Law, Medicine & Ethics, 2024, v. 52, n. 2, p. 439, doi. 10.1017/jme.2024.133

By:

Bloomfield, Doni;
Kesselheim, Aaron S.

Publication type:

Article

Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways.

Published in:

Journal of Law, Medicine & Ethics, 2020, v. 48, n. 2, p. 365, doi. 10.1177/1073110520935352

By:

Lynch, Holly Fernandez;
Bateman-House, Alison

Publication type:

Article

Generic Drug Policy and Suboxone to Treat Opioid Use Disorder.

Published in:

Journal of Law, Medicine & Ethics, 2019, v. 47, p. 43, doi. 10.1177/1073110519898042

By:

Haffajee, Rebecca L.;
Frank, Richard G.;
Blum, John D.

Publication type:

Article

Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil.

Published in:

Journal of Law, Medicine & Ethics, 2012, v. 40, n. 3, p. 673, doi. 10.1111/j.1748-720X.2012.00698.x

By:

Tomljenovic, Lucija;
Shaw, Christopher A.

Publication type:

Article

New molecular entity.

Published in:

Formulary, 2013, v. 48, n. 11, p. 359

By:

Chamberlin, Kevin W.

Publication type:

Article

Meeting Coverage. Greater vigilance needed for unapproved agents; reduce demand for these drugs by reporting adverse events.

Published in:

Formulary, 2010, v. 45, n. 11, p. 359

By:

Kaufman, Michele B.

Publication type:

Article

Renal diseases.

Published in:: Formulary, 2010, v. 45, n. 2, p. 72
Publication type:: Article

FDA Commissioner Hamburg builds agency's capabilities for bringing new therapies to patients.

Published in:: Formulary, 2010, v. 45, n. 2, p. 69
Publication type:: Article

Pipeline preview.

Published in:: Formulary, 2010, v. 45, n. 1, p. 4
Publication type:: Article

Development of orphan vaccines: an industry perspective.

Published in:

1999

By:

Lang, Jean;
Wood, Susan C.;
Lang, J;
Wood, S C

Publication type:

journal article

Botanical New Drug Applications - The Final Frontier.

Published in:

HerbalGram, 2013, n. 99, p. 66

By:

Hoffman, Freddie Ann;
Kishter, Steven R.

Publication type:

Article

Legal & Regulatory. Chinese Herbal Medicine Clears US FDA Phase II Trials.

Published in:

HerbalGram, 2010, n. 88, p. 58

By:

Stafford, Lindsay

Publication type:

Article

WHY COURTS SHOULD CONTINUE TO REJECT INNOVATOR LIABILITY THEORIES THAT SEEK TO HOLD BRANDED DRUG MANUFACTURERS LIABLE FOR GENERIC DRUG INJURIES.

Published in:

Southwestern Law Review, 2024, v. 52, n. 3, p. 580

By:

Behrens, Mark A.;
Appel, Christopher E.

Publication type:

Article

SIMPLIFYING FDASIA: THE "FAST TRACK" TO EXPEDITED DRUG APPROVAL EFFICIENCY.

Published in:

Administrative Law Review, 2014, v. 66, n. 1, p. 173

By:

JAE, VERONICA S.

Publication type:

Article

HIGH TIME FOR CHANGE: HOW FEDERAL CANNABIS PROHIBITION DOOMS THE LEGAL CANNABIS INDUSTRY.

Published in:

Journal of Business & Technology Law, 2023, v. 19, n. 1, p. 203

By:

KRUGER, ABRAHAM

Publication type:

Article

UNDUE PROCESS AT THE FDA: ANTIBIOTICS, ANIMAL FEED, AND AGENCY INTRANSIGENCE.

Published in:

Vermont Law Review, 2013, v. 37, n. 4, p. 1007

By:

Heinzerling, Lisa

Publication type:

Article

PROSPECTS FOR REGULATION OF OFF-LABEL DRUG PROMOTION IN AN ERA OF EXPANDING COMMERCIAL SPEECH PROTECTION.

Published in:

North Carolina Law Review, 2014, v. 92, n. 5, p. 1539

By:

KESSELHEIM, AARON S.;
MELLO, MICHELLE M.

Publication type:

Article

The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials.

Published in:

2007

By:

Marchetti, S;
Schellens, J H M

Publication type:

journal 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

"SHALL" WE DANCE? INTERPRETING THE BPCIA'S PATENT PROVISIONS.

Published in:

Berkeley Technology Law Journal, 2016, v. 31, p. 659, doi. 10.15779/Z383S0S

By:

Tanaka, Jon

Publication type:

Article

A SITE TO SAVE A LIFE: THE CASE FOR LOBBYING CONGRESS TO RESTRICT THE DEPARTMENT OF JUSTICE FROM TARGETING SUPERVISED DRUG CONSUMPTION SITES.

Published in:

Cornell Law Review, 2023, v. 108, n. 5, p. 1265

By:

Thompson, Trevor

Publication type:

Article