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Abbreviation : MA
Long Form : marketing authorization
No. Year Title Co-occurring Abbreviation
2019 An audit of minutes of Subject Expert Committee meetings as a metric to assess the clinical research roadmap of India. CDSCO, CT, CTW, SEC
2019 Health Technology Assessment of Drugs in Ireland: An Analysis of Timelines. HTA, NCPE, RR
2019 Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review. BRA, HTA, PP
2018 Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency. EMA, MAA, SA, SFF, SSR
2018 Cell, tissue and gene products with marketing authorization in 2018 worldwide. CGTs, ISCT
2018 Palivizumab administration in preterm infants in France: EPIPAGE-2 cohort study. RSV, TC
2018 Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety. ---
2017 Evolving prevalence of haematological malignancies in orphan designation procedures in the European Union. CML, COMP, CTCL, DLBCL, FL, MCL
2017 Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases. EMA, EU, PIP
10  2016 Accuracy of pharmaceutical company licensing predictions: projected versus actual licensing dates. MAA
11  2016 Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. EU
12  2016 Clinical development of gene- and cell-based therapies: overview of the European landscape. EU
13  2016 Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation. ATMPs, EU, GMP, HE, PIs
14  2016 Proper use of antibiotics: situation of linezolid at the intensive care unit of the Tunisian Military Hospital. ICU, VRSA
15  2015 Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012). CROs, EMA, EPAR, LROs, PEs, PROs
16  2015 The "Temporary Recommendations for Use": A dual-purpose regulatory framework for off-label drug use in France. RTUs
17  2015 [Pharmacological Basis for Therapeutics. Pharmacological Analysis of Summary of Product Characteristics (SPC) for Physicians]. EMA, SPC
18  2014 Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate. API, BCS, BE, ICH, IR
19  2014 Demonstration of biosimilarity, extrapolation of indications and other challenges related to biosimilars in Europe. ---
20  2014 Reflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJ. CHMP, EU, PSRPH, WEU
21  2014 The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children. EMA, OD, ODD, PIPs
22  2014 [A new perspective in the treatment of non-small-cell lung cancer (NSCLC). Role of afatinib: An oral and irreversible ErbB family blocker]. EGFR, NSCLC, TKI
23  2013 Off-label prescriptions: how to identify them, frame them, announce them and monitor them in practice? SPC, TUR
24  2013 Pharmacoepidemiology studies: what levels of evidence and how can they be reached? ---
25  2013 Temporary authorization for use: does the French patient access programme for unlicensed medicines impact market access after formal licensing? ATU, HTA
26  2013 [Reflections about the efficiency criteria for cancer treatments during marketing authorization application]. ---
27  2012 [Postmarketing surveillance study on the use of topotecan in small-cell lung cancer. Use of topotecan in a pneumology university department]. SCLC
28  2011 Regulatory environment for allergen-specific immunotherapy. CP, EMA, SIT
29  2011 [New treatments for diabetic retinopathy]. ---
30  2010 Assessing cancer drugs for reimbursement: methodology, relationship between effect size and medical need. ASMR, DFS, OS, PFS
31  2010 Comparators (medicinal and non medicinal) for marketing authorization, for public health, for payers and at the European level. ---
32  2010 Drug lag and key regulatory barriers in the emerging markets. CPP, FDA, GMP, LCD
33  2009 Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. NICU, PubMed
34  2008 Single technology appraisals by NICE: are they delivering faster guidance to the NHS? MTAs, NICE, STA
35  2007 [Fluticasone propionate in children and infants with asthma]. HPA
36  2006 Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years. ATC, EMEA
37  2006 Results of a market surveillance study in The Netherlands on break-mark tablets. NL, SmPC
38  2006 Selective COX-2 inhibitors and risk of thromboembolic events - regulatory aspects. CV, EMEA, GI, NSAIDs
39  2006 [Efalizumab]. ---
40  2005 Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride. APIs, BCS, BE, FI, IR, NL
41  2005 [Etanercept]. DMARDs
42  2004 Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol. BCS, IR, NL
43  2002 [Identification, during development, of a methodology targeted at determining the positioning of new drugs for therapeutic strategies: examples of rheumatoid arthritis and cardiac insufficiency]. ---
44  2002 [Regulations on gases for medical use in France]. ---