> Regulatory Affairs

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH. “Primary HLH is a [...]

2018-11-20T19:50:09+00:00 21.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity

Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India. EDQM has now suspended the manufacturer’s CEP (a certificate of compliance with European standards for quality testing), effectively prohibiting the use of its valsartan in EU medicines. In addition, national [...]

Infarmed: Sistema de Preços de Referência – Aditamento (4.º trimestre de 2018)

No âmbito do Sistema de Preços de Referência, a lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2018 foi atualizada. Consulte a área Sistema de Preços de Referência, na página Comparticipação, nomeadamente a Circular Informativa N.º 159/CD/100.20.200, de 14/11/2018 e a Deliberação N.º 81/CD/2018. Posted on the Infarmed website on [...]

2018-11-18T12:15:59+00:00 19.11.2018|Regulatory Affairs|

FDA approves new drug to treat travelers’ diarrhea

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. "Travelers' diarrhea affects millions of people each year and having treatment options for this condition can [...]

2018-11-18T12:10:11+00:00 19.11.2018|Drug Development Strategy, Regulatory Affairs|

FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labeling. However, it’s not unusual for the FDA to identify issues that [...]

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval [...]

2018-11-18T12:00:21+00:00 19.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting. The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is [...]

EMA: CHMP recommends first oral-only treatment for sleeping sickness

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on [...]

2018-11-18T11:42:25+00:00 18.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision

A report on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal from the European Union and the impact on the operation of the centralised procedure for human and veterinary medicines, published today, outlines how the European medicines regulatory network is preparing for Brexit, including EMA’s relocation and business continuity planning. At the meeting, participants were updated on EMA’s Brexit preparedness [...]

2018-11-15T19:03:59+00:00 15.11.2018|Regulatory Affairs|

EMA gives guidance on safety monitoring of medicines used in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises [...]

2018-11-13T22:24:21+00:00 14.11.2018|Pharmacovigilance, Regulatory Affairs|

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to [...]

FDA Guidance for Industry: Hypertension: Developing Fixed-Combination Drug Products for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. This guidance focuses on development of two-drug combinations of previously approved drugs, although the general approach is readily applicable to three or more drugs in combination. This guidance does not address combinations that include unapproved drug products. [...]

2018-11-12T22:42:01+00:00 13.11.2018|Regulatory Affairs, Training|

EMA: Human medicines highlights – November 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and does not necessarily cover all [...]

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic [...]

2018-11-11T13:02:36+00:00 12.11.2018|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos Julio – Septiembre 2018

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge información sobre la evolución de la legislación de estos productos, los documentos técnicos y científicos publicados, las actuaciones de vigilancia y [...]

Infarmed: Fenilefrina Aguettant (Fenilefrina) – Avaliação prévia hospitalar concluída

O medicamento Fenilefrina Aguettant (Fenilefrina) obteve autorização para ser utilizado em meio hospitalar na indicação: Tratamento de hipotensão durante a anestesia espinal, epidural ou geral. De acordo com a avaliação farmacoterapêutica, conclui-se que existe sugestão de equivalência terapêutica no tratamento da hipotensão durante a anestesia espinal, epidural ou geral, face a medicamentos com a mesma [...]

2018-11-09T16:26:44+00:00 09.11.2018|Regulatory Affairs|

(Cas) AEMPS: Publicación de la resolución con el listado de productos homeopáticos notificados al amparo de la orden ministerial para su procedimiento de registro

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.El pasado 30 de abril, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) anunció la publicación de la Orden Ministerial  que determinaba los [...]

2018-11-06T20:50:57+00:00 07.11.2018|Regulatory Affairs|

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands). “For some patients with parathyroid disease, treatment may mean a surgical [...]

2018-11-08T22:44:22+00:00 07.11.2018|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Preguntas y respuestas sobre regulación de medicamentos de terapia avanzada

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Sección divulgativa que pretende ayudar a conocer algunos aspectos prácticos de la regulación de los medicamentos de terapia avanzada, dirigida en particular [...]

2018-11-06T20:44:47+00:00 06.11.2018|Regulatory Affairs|