Works matching DE "DRUG approval laws"
Results: 216
Good drug, bad luck: business, regulatory issues can create obstacles for drug development.
- Published in:
- 2004
- By:
- Publication type:
- journal article
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:
- Publication type:
- Article
Role of the FDA in Affordability of Off-Patent Pharmaceuticals.
- Published in:
- 2016
- By:
- Publication type:
- journal article
Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research.
- Published in:
- 2021
- By:
- Publication type:
- Editorial
Uncertainty in the generic versus brand name prescription decision.
- Published in:
- Empirical Economics, 2010, v. 38, n. 3, p. 503, doi. 10.1007/s00181-009-0277-7
- By:
- Publication type:
- Article
Lack of effect of the European guidance on clinical investigation of medicines in children.
- Published in:
- 2002
- By:
- Publication type:
- journal article
ALGORITHMIC REASON-GIVING, ARBITRARY AND CAPRICIOUS REVIEW, AND THE NEED FOR A CLEAR NORMATIVE BASELINE.
- Published in:
- University of Cincinnati Law Review, 2024, v. 93, n. 1, p. 40
- By:
- 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:
- Publication type:
- Article
Eyes on New Product Development.
- Published in:
- 2020
- By:
- Publication type:
- journal article
Eyes on New Product Development.
- Published in:
- 2018
- By:
- Publication type:
- journal 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:
- 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:
- 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:
- 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:
- Publication type:
- Correction Notice
Alternate approaches for pediatric type 1 diabetes drug development and potential regulatory approval: a perspective.
- Published in:
- 2015
- By:
- Publication type:
- journal article
Putting the "good" into Good Clinical Practice.
- Published in:
- 2021
- By:
- Publication type:
- journal article
Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.
- Published in:
- 2018
- By:
- Publication type:
- journal article
The Timing of Cancer Drug Approvals in the United States and Europe.
- Published in:
- 2022
- By:
- Publication type:
- Opinion
Mechanical Circulatory Support: Historical Perspective.
- Published in:
- Cardiovascular Journal, 2022, v. 15, n. 1, p. 74, doi. 10.3329/cardio.v15i1.61914
- By:
- Publication type:
- Article
Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.
- Published in:
- 2016
- By:
- 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:
- Publication type:
- journal article
Post-Marketing Surveillance of Prescription Drug Safety: Past, Present, and Future.
- Published in:
- Journal of Legal Medicine, 2013, v. 34, n. 2, p. 193, doi. 10.1080/01947648.2013.800797
- By:
- Publication type:
- Article
EARNING EXCLUSIVITY: GENERIC DRUG INCENTIVES AND THE HATCH-WAXMAN ACT.
- Published in:
- Antitrust Law Journal, 2011, v. 77, n. 3, p. 947
- By:
- Publication type:
- Article
Neuromodulation Remote Programming vs. In-Person Office Appointments: An Assessment of Reimbursement Levels.
- Published in:
- Proceedings of the Northeast Business & Economics Association, 2021, p. 227
- By:
- Publication type:
- Article
THERE'S A HOLE IN MY BUCKET DEAR LIZA, DEAR LIZA: THE 30-YEAR ANNIVERSARY OF THE HATCHWAXMAN ACT: RESOLVED AND UNRESOLVED GAPS AND COURT-DRIVEN POLICY GAP FILLING.
- Published in:
- William Mitchell Law Review, 2014, v. 40, n. 4, p. 1307
- By:
- Publication type:
- Article
RxLegal: Emergency Use Authorizations.
- Published in:
- Hospital Pharmacy, 2023, v. 58, n. 1, p. 16, doi. 10.1177/00185787221130703
- By:
- 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:
- Publication type:
- Article
Pharmaceutical pricing conundrum: time to get rid of it?
- Published in:
- 2018
- By:
- 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:
- Publication type:
- journal article
Patient access to pharmaceuticals: an international comparison.
- Published in:
- 2007
- By:
- Publication type:
- journal article
Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia.
- Published in:
- Health Care Analysis, 2023, v. 31, n. 3/4, p. 196, doi. 10.1007/s10728-023-00465-9
- By:
- Publication type:
- Article
Seven days: 22-28 June 2012.
- Published in:
- Nature, 2012, v. 486, n. 7404, p. 444, doi. 10.1038/486444a
- Publication type:
- Article
Patent watch: Have the biosimilar floodgates been opened in the United States?
- Published in:
- Nature Reviews Drug Discovery, 2015, v. 14, n. 5, p. 303, doi. 10.1038/nrd4622
- By:
- Publication type:
- Article
European regulatory experience with drugs for central nervous system disorders.
- Published in:
- Nature Reviews Drug Discovery, 2015, v. 14, n. 2, p. 89, doi. 10.1038/nrd4511
- By:
- Publication type:
- Article
Regulatory watch: Innovation in biologic new molecular entities: 1986-2014.
- Published in:
- Nature Reviews Drug Discovery, 2015, v. 14, n. 2, p. 83, doi. 10.1038/nrd4535
- By:
- 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
Proposals to speed up European drug approval process questioned.
- Published in:
- 2001
- By:
- Publication type:
- journal article
New molecular entity.
- Published in:
- Formulary, 2013, v. 48, n. 11, p. 359
- By:
- 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:
- 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
The Oncology Pipeline Overview: Recent Approvals and Near-Term Drugs.
- Published in:
- Journal of Hematology Oncology Pharmacy, 2021, v. 11, n. 6, p. 340
- Publication type:
- Article
HOW NON-PRODUCT-SPECIFIC MANUFACTURING PATENTS BLOCK BIOSIMILARS.
- Published in:
- Duke Law Journal, 2022, v. 71, n. 8, p. 1923
- By:
- Publication type:
- Article
Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
- Published in:
- Current Medical Research & Opinion, 2011, v. 27, n. 2, p. 315, doi. 10.1185/03007995.2010.542135
- By:
- Publication type:
- Article
Changes to the FDA Approval Process.
- Published in:
- Penn Bioethics Journal, 2016, v. 13, n. 1, p. 7
- Publication type:
- Article
House passes 12st Century Cures Act.
- Published in:
- Ocular Surgery News, 2015, v. 33, n. 15, p. 34
- By:
- 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:
- Publication type:
- Article
Competition from Biosimilars an Incentive for Innovation.
- Published in:
- American Health & Drug Benefits, 2010, v. 3, n. 1, p. 27
- By:
- Publication type:
- Article