Generics - Pharmaceutical, Regulation


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FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition


The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining…


Hikma’s US facility back in compliance

Hikma’s US facility back in compliance


Hikma Pharmaceuticals, Jordan's largest pharmaceutical company, has received a close-out letter from…

GenericsHikma PharmaceuticalsJordanPharmaceuticalRegulation

US FDA approves NDA from Actavis and Valeant

US FDA approves NDA from Actavis and Valeant


US generics major Actavis and Canada’s Valeant Pharmaceuticals said that the US Food and Drug Administration…

ActavisCanadaGenericsMetronidazolePharmaceuticalRegulationUSAValeant PharmaceuticalsWomen's Health

Indian drugmakers readying for next “Patent cliff”


The strategic drug reviews, as well as mergers and acquisitions – such as Actavis buying out Forest…

Asia-PacificGenericsIndiaMergers & AcquisitionsPatentsPharmaceuticalRegulation

Canada's Health Minister sets out plan to help reduce impact of drug shortages


A national protocol for the public notification of drug shortages and a toolkit that identifies steps…

GenericsHealthcareNorth AmericaPharmaceuticalRegulation

US FDA accepts Pennsaid 2% NDA for review


The US Food and Drug Administration has accepted for filing US drugmaker Mallinckrodt's (NYSE: MNK) New…

Anti-Arthritics/RheumaticsGenericsMallinckrodtNorth AmericaNuvo ResearchPennsaidPharmaceuticalRegulation

Japan's MHLW approves 367 generics, but what does this mean?


Japan's Ministry of Health Labor and Welfare (MHLW) approved 367 items of generic drugs last week. Launch…


Proposed Bill for South Africa Health Products Regulatory Authority


The South African Minister of Health has published the proposed amendments to the Medicines and Related…

GenericsPharmaceuticalRegulationRest of the World

New Zealand approves proposals diazepam, gabapentin and naltrexone listing


New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval of proposals relating…


Treatments for malaria, sleeping sickness and Chagas disease added to WHO's list of pediatric medicines


The World Health Organization has released its updated Model List for Essential Medicines for Children…

artesunate-mefloquineBayerbenznidazoleCiplaGenericsGlobalNifurtimox-eflornithinePharmaceuticalRegulationSanofiTropical diseases

FDA plans to revise drug labeling regulations by September


The US Food and Drug Administration says it plans to issue a proposed rule to revise FDA regulations…

GenericsNorth AmericaPharmaceuticalRegulation

Indian pharma threatened by trend of shifting R&D operations overseas: survey


Red tape is putting India's multi-billion dollar worth pharmaceutical industry at risk, with most of…

Asia-PacificGenericsMarkets & MarketingPharmaceuticalRegulationResearch

EU falsified medicines directive: imported active substances need written confirmation to guarantee GMP standards


From July 2, 2013, all active substances manufactured outside of the European Union and imported into…


Waiver from European Commission to help exporting for US pharmaceutical manufacturers


The US Food and Drug Administration announced on Friday (June 21) that the USA is now a "listed country"…

EuropeGenericsNorth AmericaPharmaceuticalProductionRegulation

June meeting highlights from EMA Pharmacovigilance Risk Assessment Committee


The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has made several recommendations…


China forms global alliance with Germany's blue inspection for drug quality


Effective June 1, 2013, the China Chamber of Commerce for Import & Export of Medicines & Health Products…


Irish Medicines Board drawing up list of generic drugs to help reduce costs


In Ireland, drugs to treat medical conditions such as high cholesterol, blood pressure and stomach ulcers…


Tightening health budgets on both sides of the Atlantic leading to crackdowns on patent settlements, says EIU analyst


Later this month, following an inquiry launched in 2009, the European Commission is expected to impose…

EuropeFinancialGenericsNorth AmericaPatentsPharmaceuticalPoliticsRegulation

CPhI Russia highlights growth in domestic manufacturing and international partnering


Presentations at the CPhI Russia event which took place in April reflected growth in the Russian pharma…


Boehringer Ingelheim gets FDA warning letter on cGMP failures


German family-owned drug major Boehringer Ingelheim today (May 22) revealed that the US Food and Drug…

Boehringer IngelheimGenericsPharmaceuticalProductionRegulation

US FDA to allow generic copies of Endo's Opana


Endo Health Solutions (Nasdaq: ENDP) announced Friday (May 10) that the US Food and Drug Administration…

Endo Health SolutionsEndo PharmaceuticalsGenericsNeurologicalNorth AmericaOpana ERPharmaceuticalRegulation

Canada strengthens drug safety with GMP now to apply to all APIs


Canada's Health Minister Leona Aglukkaq this week announced that Canada's Food and Drug Regulations have…

GenericsNorth AmericaPharmaceuticalProductionRegulation

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