Works matching DE "DRUG approval laws"

Results: 223

Navigating the next surge: a perspective on Egypt's preparedness and prospects for another COVID-19 outbreak.

Published in:

Population Health Metrics, 2025, v. 23, n. 1, p. 1, doi. 10.1186/s12963-025-00398-6

By:

Elhosseiny, Aliaa A.;
Salama, Mohamed

Publication type:

Article

FDA APPROVAL OF DRUGS AND DEVICES: PREEMPTION OF STATE LAWS FOR "PARALLEL" TORT CLAIMS.

Published in:

Journal of Health Care Law & Policy, 2015, v. 18, n. 1, p. 1

By:

BOUMIL, MARCIA

Publication type:

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

Administration of Co-Phenylcaine Forte nasal spray during nasendoscopy: Implementing and evaluating this extended scope role for speech-language pathologists.

Published in:

Journal of Clinical Practice in Speech-Language Pathology, 2018, v. 20, n. 2, p. 70

By:

Schwarz, Maria;
Ward, Elizabeth C.;
Seabrook, Marnie;
Coccetti, Anne;
Whitfield, Bernard C. S.

Publication type:

Article

Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.

Published in:

2016

By:

Goldman, Stephen;
Goldman, Stephen A

Publication type:

journal article

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

Published in:

2015

By:

Kesselheim, Aaron;
Gagne, Joshua;
Kesselheim, Aaron S;
Gagne, Joshua J

Publication type:

journal 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

"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

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

The Timing of Cancer Drug Approvals in the United States and Europe.

Published in:

2022

By:

Jenei, Kristina

Publication type:

Opinion

FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022.

Published in:

Journal of Law, Medicine & Ethics, 2025, v. 53, n. 1, p. 137, doi. 10.1017/jme.2025.53

By:

Zhang, Audrey D.;
Chaudhry, Nikhil;
Ramachandran, Reshma;
Ross, Joseph S.;
Schwartz, Jason L.

Publication type:

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

U.S.Food and Drug Administration Approval Summary:Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations.

Published in:

Oncologist, 2014, v. 19, n. 7, p. 774, doi. 10.1634/theoncologist.2014-0089

By:

Khozin, Sean;
Blumenthal, Gideon M.;
Jiang, Xiaoping;
He, Kun;
Boyd, Karen;
Murgo, Anthony;
Justice, Robert;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

Mechanical Circulatory Support: Historical Perspective.

Published in:

Cardiovascular Journal, 2022, v. 15, n. 1, p. 74, doi. 10.3329/cardio.v15i1.61914

By:

Anisuzzaman, Md.;
Hosain, Nazmul;
Rahman, Mohammad Rafiur

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

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

QUALIFYING INTELLECTUAL PROPERTY I: HARMONIZED MEASUREMENT OF NEW AND FOLLOWON DRUG APPROVALS, PATENTS AND CHEMICAL COMPONENTS.

Published in:

Journal of Science & Technology Law, 2012, v. 18, n. 1, p. 38

By:

Bouchard, Ron A.

Publication type:

Article

THE HIPAA PRIVACY RULE AT AGE 25: PRIVACY FOR EQUITABLE AI.

Published in:

Florida State University Law Review, 2023, v. 50, n. 4, p. 741

By:

EVANS, BARBARA J.

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

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

New molecular entities and new biologicals, 2014.

Published in:: American Journal of Health-System Pharmacy, 2015, v. 72, n. 3, p. 181
Publication type:: Article

Pharmacotherapy for alcoholic patients with alcoholic liver disease.

Published in:

American Journal of Health-System Pharmacy, 2014, v. 71, n. 15, p. 1265, doi. 10.2146/ajhp140028

By:

VUITTONET, CYNTHIA L.;
HALSE, MICHAEL;
LEGGIO, LORENZO;
FRICCHIONE, SAMUEL B.;
BRICKLEY, MICHAEL;
HAASS-KOFFLER, CAROLINA L.;
TAVARES, TONYA;
SWIFT, ROBERT M.;
KENNA, GEORGE A.

Publication type:

Article

Inhaled insulin product approved.

Published in:

2014

By:

Traynor, Kate

Publication type:

Product Review

News Briefs.

Published in:: American Journal of Health-System Pharmacy, 2013, v. 70, n. 2, p. 95
Publication type:: Article

Cabozantinib approved for advanced medullary thyroid cancer.

Published in:

American Journal of Health-System Pharmacy, 2013, v. 70, n. 2, p. 88, doi. 10.2146/news130005

By:

Traynor, Kate

Publication type:

Article

FDA approves tofacitinib for rheumatoid arthritis.

Published in:

American Journal of Health-System Pharmacy, 2012, v. 69, n. 24, p. 2120, doi. 10.2146/news120088

By:

Traynor, Kate

Publication type:

Article

News Briefs.

Published in:: American Journal of Health-System Pharmacy, 2012, v. 69, n. 23, p. 2032, doi. 10.1093/ajhp/69.23.2032
Publication type:: Article

RxLegal: Emergency Use Authorizations.

Published in:

Hospital Pharmacy, 2023, v. 58, n. 1, p. 16, doi. 10.1177/00185787221130703

By:

Gabay, Michael;
Vora, Niam

Publication type:

Article

Off-Label Drug Promotion and the Use of Disclaimers.

Published in:

Texas Law Review, 2013, v. 92, n. 1, p. 231

By:

McKenney, Dina

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

ABPI RESPONDS TO GOV ANNOUNCEMENT ON AAC AND FASTER ACCESS TO MEDICINES.

Published in:: Operating Theatre Journal, 2019, n. 344, p. 12
Publication type:: Article

COVID-19, racism, and the pursuit of health care and research worthy of trust.

Published in:

Journal of Clinical Investigation, 2020, v. 130, n. 10, p. 5033, doi. 10.1172/jci141562

By:

Cooper, Lisa A.;
Crews, Deidra C.

Publication type:

Article

What Is the Purpose of the Orphan Drug Act?

Published in:

2017

By:

Herder, Matthew

Publication type:

journal 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

Reviving Essential Facilities to Prevent REMS Abuses.

Published in:

Columbia Journal of Law & Social Problems, 2013, v. 47, n. 2, p. 103

By:

MEGAW, CHRISTOPHER

Publication type:

Article

The FDA and DHS Blessing of Security Technologies: Positive Contributions to Security or Security Theater?

Published in:

Journal of Physical Security, 2022, v. 15, n. 1, p. 48

By:

Johnston, Roger G.

Publication type:

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