scholarly journals Farmaci orfani e malattie rare: la situazione in Italia

2001 ◽  
Vol 2 (4) ◽  
pp. 261-266
Author(s):  
S. Martina ◽  
C. Denti ◽  
E. Daina ◽  
L. Garattini
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Ministry Of Health ◽  
Italian Market ◽  
The World ◽  
Economic Profile

Aim of this study is to check the Italian market of the orphan drugs in connection with rare diseases. Data for the research have been found on the Food and Drug Administration Database, the Centro di Ricerche Cliniche per le Malattie Rare “Aldo e Cele Daccò” Database and L’informatore farmaceutico. This study also compared the Italian market with the American market, that counts the greater number of designated orphan drugs and commercial authorizations in the world. In Italy only 24 orphan drugs have been authorized by the Ministry of Health and the present work analyzes their definition under the economic profile, how many diseases and what kind of pathologies they can treat, the number of products on the market and if they are refundable or not.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals KEWENANGAN BADAN PENGAWAS OBAT DAN MAKANAN TERHADAP PERDA PROVINSI BALI NO 5 TAHUN 2012 TENTANG PENGENDALIAN PEREDARAN MINUMAN BERALKOHOL

2013 ◽  
Vol 2 (3) ◽  
Author(s):  
I Putu Mahentoro
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Alcoholic Beverage ◽  
Provincial Government ◽  
Alcoholic Beverages ◽  
Ministry Of Health ◽  
The Public ◽  
The Republic ◽  
The Government ◽  
Imported Foods

ABSTRACTThe research was conducted based on the same authority which is ownedby the two institutions, namely Food and Drug Administration of the Republic ofIndonesia and Bali Provicial Government in monitoring and controlling ofalcoholic beverages in Bali.The results of this study demonstrate the Food and Drug Administrationand the Provincial Government of Bali have the same authority to supervise andcontrol alcoholic beverages in Bali. Bali Local Government Regulation Number 5of 2012 on the Circulation of Alcoholic Beverage Control only requires each hasa label on alcoholic beverages issued by the Government of Bali has to bedistributed to the public, while the authority of the Food and Drug Administrationis regulated in the Regulation of Minister of Health of the Republic of IndonesiaNumber 382/MENKES/PER/VI/1989 on Registration of Food that requires allfood produced both by local producers and imported foods are required to beregistered to the Ministry of Health through the Food and Drug Administration.In the Regulation Number 5 Year 2012 did not include the authority of theFood and Drug Administration (the Empty Norms) so that the Food and DrugAdministration can not perform optimally the law enforcement againstmanufacturers, distributors and sellers of alcoholic beverages in violation. Tocope with the condition it should be a amendment in the Bali ProvincialRegulation Number 5 of 2012 by stating firmly and clearly the authority of theFood and Drug Administration related to the registration of food, which requiresthat for all foods and beverages that will be distributed to the public must beregistered to the Ministry of Health through the Food and Drug Administration.

PLAN TO SPEED APPROVAL OF DRUGS: MAKERS WOULD PAY FEES TO U.S

PEDIATRICS ◽  
1993 ◽  
Vol 92 (4) ◽  
pp. 558-558
Author(s):  
J. F. L.
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Drug Industry ◽  
Staff Members ◽  
Life Saving ◽  
Congressional Staff ◽  
The Government ◽  
Biotechnology Products

WASHINGTON, Aug. 10—The Government and the drug industry are near an agreement to require the companies to pay fees that would be used by the Food and Drug Administration to hire 600 new examiners and speed approval of drugs, officials on both sides said today. The agreement, being worked out by Congressional staff members, is intended to resolve what both the Government and industry have said for the last few years is a catastrophe waiting to happen: the number of drug applications is rapidly increasing, especially because of the boom in biotechnology products, some of which might save lives if they were available. But the F.D.A. has not had enough staff members to keep up. Advocates of people with AIDS, cancer and rare diseases have all pressed for quicker approval of potentially life-saving drugs, for time can be crucial in treatment.

scholarly journals Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration

2018 ◽  
Vol 6 (1) ◽  
pp. 1433426
Author(s):  
Szymon Jarosławski ◽  
Pascal Auquier ◽  
Borislav Borissov ◽  
Claude Dussart ◽  
Mondher Toumi
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
The Us

EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal filler products

2020 ◽  
Vol 9 (8) ◽  
pp. 320-324
Author(s):  
Kate Kelso
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Dermal Filler ◽  
The World ◽  
The Uk ◽  
The Eu ◽  
Medical Device Regulation

Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) ( EU 2017 /745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective.

INSIDE INDUSTRY

2015 ◽  
Vol 19 (06) ◽  
pp. 35-39
Keyword(s):  
Bladder Cancer ◽  
Drug Administration ◽  
Rare Diseases ◽  
Oncolytic Virus ◽  
Food And Drug Administration ◽  
Phase Iii ◽  
Cancer Drugs ◽  
Research Risks ◽  
Lost Decade

Two Promising Phase III Cancer Drugs: SIRT & Afatinib CAVATAK™ Presentations at Oncolytic Virus Therapeutics Conference Reinforce Potential in Bladder Cancer and Melanoma Receptos subjected to M&A Speculation Antibiotics Research Risks another Lost Decade while Rare Diseases Research Steams Ahead, Global Patent Study Reveals Intertek gains Official Accreditation with Philippines Food and Drug Administration

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