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A paradigm shift in evaluation of new medications for older adults—A mandate has arrived!
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- Journal of the American Geriatrics Society, 2024, v. 72, n. 9, p. 2892, doi. 10.1111/jgs.19028
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- Publication type:
- Article
Pharmaceutical pricing conundrum: time to get rid of it?
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- 2018
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- 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.
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- 2017
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- Publication type:
- journal article
Patient access to pharmaceuticals: an international comparison.
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- 2007
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- Publication type:
- journal article
Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.
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- Pan American Journal of Public Health / Revista Panamericana de Salud Pública, 2021, v. 45, p. 1, doi. 10.26633/RPSP.2021.10
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- Publication type:
- Article
Biosimilars in oncology in Canada and the role of nurses.
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- Canadian Oncology Nursing Journal, 2019, v. 29, p. 1
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- Publication type:
- Article
OP30 Health Technology Assessment And The Decision-Making Process Of New Drug Listing In Hong Kong.
- Published in:
- 2017
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- Publication type:
- Abstract
Reviving Essential Facilities to Prevent REMS Abuses.
- Published in:
- Columbia Journal of Law & Social Problems, 2013, v. 47, n. 2, p. 103
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- Publication type:
- Article
The FDA and DHS Blessing of Security Technologies: Positive Contributions to Security or Security Theater?
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- Journal of Physical Security, 2022, v. 15, n. 1, p. 48
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- Publication type:
- Article
Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?
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- American Journal of Public Health, 2017, v. 107, n. 11, p. 1752, doi. 10.2105/AJPH.2017.304093
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- Publication type:
- Article
THE HATCH-WAXMAN ACT'S SIDE EFFECTS: PRECAUTIONS FOR BIOSIMILARS.
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- Loyola of Los Angeles Law Review, 2014, v. 47, n. 4, p. 917
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- Publication type:
- Article
THE HIPAA PRIVACY RULE AT AGE 25: PRIVACY FOR EQUITABLE AI.
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- Florida State University Law Review, 2023, v. 50, n. 4, p. 741
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- Publication type:
- Article
Jon M. Hanifin ‐ A career of discovery, mentorship, advocacy, and scientific rigor.
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- Allergy, 2022, v. 77, n. 7, p. 2257, doi. 10.1111/all.15303
- Publication type:
- Article
Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe.
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- Clinical Pharmacology & Therapeutics, 2010, v. 88, n. 6, p. 848, doi. 10.1038/clpt.2010.207
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- Publication type:
- Article
"Plasma exchange in a bottle": An overview of efgartigimod for apheresis practitioners.
- Published in:
- Journal of Clinical Apheresis, 2022, v. 37, n. 5, p. 512, doi. 10.1002/jca.22002
- Publication type:
- Article
Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics.
- Published in:
- JAMA Network Open, 2023, v. 6, n. 8, p. e2331753, doi. 10.1001/jamanetworkopen.2023.31753
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- Publication type:
- Article
Follow-On Indications for Orphan Drugs Related to the Inflation Reduction Act.
- Published in:
- JAMA Network Open, 2023, v. 6, n. 8, p. e2329006, doi. 10.1001/jamanetworkopen.2023.29006
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- Publication type:
- Article
Prescribing "Off-Label": What Should a Physician Disclose?
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- AMA Journal of Ethics, 2016, v. 18, n. 6, p. 587, doi. 10.1001/journalofethics.2016.18.6.ecas3-1606
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- Publication type:
- Article
The use of mechanistic evidence in drug approval.
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- Journal of Evaluation in Clinical Practice, 2018, v. 24, n. 5, p. 1166, doi. 10.1111/jep.12960
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- Publication type:
- Article
Development of orphan vaccines: an industry perspective.
- Published in:
- 1999
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- Publication type:
- journal article
SIMPLIFYING FDASIA: THE "FAST TRACK" TO EXPEDITED DRUG APPROVAL EFFICIENCY.
- Published in:
- Administrative Law Review, 2014, v. 66, n. 1, p. 173
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- Publication type:
- Article
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018.
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- Clinical Trials, 2021, v. 18, n. 4, p. 488, doi. 10.1177/17407745211005044
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- Publication type:
- Article
To Try or Not to Try: Who Decides Is the Question.
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- FDCC Quarterly, 2015, v. 64, n. 4, p. 311
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- Publication type:
- Article
Uncertainty in the generic versus brand name prescription decision.
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- Empirical Economics, 2010, v. 38, n. 3, p. 503, doi. 10.1007/s00181-009-0277-7
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- Publication type:
- Article
UNDUE PROCESS AT THE FDA: ANTIBIOTICS, ANIMAL FEED, AND AGENCY INTRANSIGENCE.
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- Vermont Law Review, 2013, v. 37, n. 4, p. 1007
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- Publication type:
- Article
THE EVOLUTION OF PHARMACEUTICAL REGULATORY GAMING PRACTICES.
- Published in:
- Seton Hall Law Review, 2017, v. 47, n. 3, p. 849
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- Publication type:
- Article
Implementation of the Biosimilar Pathway: Economic and Policy Issues.
- Published in:
- Seton Hall Law Review, 2011, v. 41, n. 2, p. 511
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- Publication type:
- Article
Miracle drug: Brazil approves never-tested cancer medicine.
- Published in:
- Journal of Oncology Pharmacy Practice, 2017, v. 23, n. 5, p. 399, doi. 10.1177/1078155216665246
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- Publication type:
- Article
Updating professional development for medical librarians to improve our evidence-based medicine and information literacy instruction.
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- Journal of the Medical Library Association, 2018, v. 106, n. 3, p. 383, doi. 10.5195/jmla.2018.386
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- Publication type:
- Article
Seven days: 22-28 June 2012.
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- Nature, 2012, v. 486, n. 7404, p. 444, doi. 10.1038/486444a
- Publication type:
- Article
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of GEJ Adenocarcinoma.
- Published in:
- Value-Based Cancer Care, 2023, v. 14, n. 6, p. 12
- Publication type:
- Article
Drug Sourcing Matters: Protecting Patients Facing Drug Importation, White and Brown Bagging.
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- Oncology Practice Management, 2024, v. 14, n. 7, p. 6
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- Publication type:
- Article
Good drug, bad luck: business, regulatory issues can create obstacles for drug development.
- Published in:
- 2004
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- Publication type:
- journal article
Proposals to speed up European drug approval process questioned.
- Published in:
- 2001
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- Publication type:
- journal 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
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- Publication type:
- Article
Over-the-Counter Oral Contraceptives to Reduce Unintended Pregnancies.
- Published in:
- 2020
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- Publication type:
- journal article
FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
- Published in:
- 2020
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- Publication type:
- journal article
Reform at the FDA-In Need of Reform.
- Published in:
- 2020
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- Publication type:
- editorial
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.
- Published in:
- 2018
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- Publication type:
- journal article
Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.
- Published in:
- 2018
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- Publication type:
- journal article
New "21st Century Cures" Legislation: Speed and Ease vs Science.
- Published in:
- 2017
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- Publication type:
- journal article
The Pediatric Research Equity Act Moves Into Adolescence.
- Published in:
- 2017
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- Publication type:
- journal article
Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy.
- Published in:
- 2016
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- Publication type:
- journal article
Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations?
- Published in:
- 2016
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- Publication type:
- journal article
Role of the FDA in Affordability of Off-Patent Pharmaceuticals.
- Published in:
- 2016
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- Publication type:
- journal article
Erratum in: Comparative efficacies of Calmare® therapy and transcutaneous electrical nerve stimulation in randomized peripheral neuropathy subjects with resting state fMRI monitoring.
- Published in:
- Journal of Pain Management, 2021, v. 14, n. 1, p. 75
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- 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
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- Publication type:
- Article
Changes Coming in Pain Management?
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- South Dakota Medicine, 2014, v. 67, n. 3, p. 108
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- 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
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- 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
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- Publication type:
- Article