> Regulatory Affairs

FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions. “One of our most important obligations is to protect consumers [...]

2019-03-20T09:51:31+00:0020.03.2019|Pharmacovigilance, Regulatory Affairs|

FDA Guidance for Industry: Severely Debilitating or LifeThreatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

The purpose of this guidance is to assist sponsors in the design of nonclinical studies for the development of pharmaceuticals used to treat patients with severely debilitating or lifethreatening hematologic disorders (SDLTHDs). This guidance is intended to streamline the development of pharmaceuticals used to treat patients with SDLTHDs, other than cancer, while still protecting patients’ safety and avoiding [...]

2019-03-18T22:12:07+00:0019.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products

The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate the effectiveness of drug and biological products. Enrichment is the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is [...]

2019-03-18T21:39:05+00:0019.03.2019|Regulatory Affairs, Training|

UK MHRA: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal

Leaving the EU with a deal remains the government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario. If the UK leaves the EU on 29 March 2019 without a deal, the following legal obligations will apply to marketing authorisation holders (MAH) in the UK: To operate a [...]

2019-03-18T21:33:02+00:0018.03.2019|Regulatory Affairs, Training|

FDA allows marketing of new device to help treat carbon monoxide poisoning

The U.S. Food and Drug Administration today allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s rate of breathing. “Carbon monoxide [...]

2019-03-17T18:28:05+00:0017.03.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause heart failure symptoms such as shortness of breath, fatigue and swelling [...]

2019-03-17T18:22:25+00:0017.03.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Medicamento para prevenção da atonia uterina sem vantagem face às alternativas existentes (Pabal – Carbetocina – Avaliação prévia hospitalar concluída)

O medicamento Pabal (Carbetocina) foi objeto de indeferimento da avaliação prévia hospitalar na indicação: ¿Pabal está indicado para a prevenção da atonia uterina após a expulsão do bebé por cesariana sob anestesia epidural ou espinal.? Pabal deu prova de equivalência terapêutica face à alternativa comparadora oxitocina, traduzindo-se em resultados clínicos sobreponíveis globalmente na indicação clínica [...]

2019-03-14T22:26:22+00:0015.03.2019|Regulatory Affairs|

FDA approves a new generic valsartan

Today, the U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic [...]

2019-03-14T22:15:54+00:0014.03.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Aprovada lista dos grupos homogéneos e dos preços de referência em vigor no 2.º trimestre de 2019

A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 2.º trimestre de 2019 foi aprovada e entra em vigor a 1 de abril de 2019. Consulte a área Sistema de Preços de Referência, na página Comparticipação, nomeadamente, a Circular Informativa N.º 56/CD/100.20.200, de 08/03/2019 e a Deliberação N.º 21/CD/2019. Posted on the Infarmed website on 12 [...]

2019-03-12T20:48:53+00:0012.03.2019|Regulatory Affairs|

Infarmed: Atualização de perguntas e respostas no âmbito da inspeção na área “Brexit”

Foram atualizadas as perguntas e respostas relativas ao impacto nas atividades de inspeção na área Brexit do site do Infarmed de modo a incluir os procedimentos referentes aos pedidos de exceção para continuação da realização de ensaios de controlo de qualidade no Reino Unido após a sua saída da União Europeia, para produtos autorizados a nível nacional. [...]

2019-03-12T20:44:40+00:0012.03.2019|Regulatory Affairs|

FDA Guidance for Industry: Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the inclusion of adolescent patients in disease- and target-appropriate adult oncology clinical trials to [...]

2019-03-12T20:40:12+00:0012.03.2019|Regulatory Affairs, Training|

(Cas) AEMPS: Solicitudes de exención por tiempo limitado para seguir llevando a cabo los análisis de control de lotes de medicamentos en el Reino Unido después de la fecha brexit

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. La AEMPS informa sobre la posibilidad de solicitar la exención temporal de la obligatoriedad de llevar a cabo análisis de control [...]

2019-03-10T10:40:03+00:0011.03.2019|Regulatory Affairs|

FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato [...]

2019-03-10T10:30:36+00:0011.03.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Atualização da Informação de Medicamentos (alterações C.I.z. IAIN)

O Infarmed solicitou à EMA as seguintes alterações ao template Quality Review of Documents (QRD): - Folheto Informativo - Alteração dos termos "efeitos secundários" para "efeitos indesejáveis"; - RCM e FI - Atualização dos contactos para notificação de suspeitas de reações adversas /efeitos indesejáveis, com a finalidade de privilegiar a utilização do Portal RAM. Na sequência deste [...]

2019-03-10T10:23:44+00:0010.03.2019|Regulatory Affairs|

ANSM: Pour un accès rapide à l’innovation thérapeutique, toutes les demandes d’ATU nominatives peuvent être dématérialisées via l’application e-Saturne

A partir d’aujourd’hui, toutes les demandes d’Autorisation Temporaire d’Utilisation nominatives (ATUn) de médicaments, peuvent être transmises par les professionnels de santé à l’ANSM via l’application e-Saturne. Celle-ci simplifie les échanges entre l’hôpital et l’Agence afin de donner un accès plus rapide aux traitements en ATUn pour les patients qui en ont besoin. Ce mode de [...]

2019-03-10T10:20:18+00:0010.03.2019|Drug Development Strategy, Regulatory Affairs|

EMA Regulatory information – adjusted fees for applications to EMA from 1 April 2019

The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2019. Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2018 [...]

2019-03-10T10:09:06+00:0010.03.2019|Regulatory Affairs|

EMA: New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus. Zynquista is a small molecule with dual inhibitor activity on SGLT1 and SGLT2. It works in the kidneys to prevent reabsorption of glucose from the urine and in [...]

2019-03-07T21:30:50+00:0007.03.2019|Drug Development Strategy, Regulatory Affairs|

EMA: First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding. Anticoagulants are used to [...]

2019-03-07T21:23:04+00:0007.03.2019|Drug Development Strategy, Regulatory Affairs|

EMA: CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease

EMA’s human medicines committee (CHMP) has recommended the authorisation of Palynziq (pegvaliase), a new medicine for patients aged 16 and older with phenylketonuria, a rare but potentially serious inherited metabolic disease. Patients suffering from this disorder do not have the enzyme that breaks down phenylalanine, an amino acid which is found in most foods containing [...]

2019-03-04T22:52:15+00:0005.03.2019|Drug Development Strategy, Regulatory Affairs|

EMA: First treatment for rare disease characterised by high levels of triglycerides in blood

The European Medicines Agency has recommended granting a conditional marketing authorisation (CMA) for Waylivra (volanesorsen), the first medicine for the treatment of the familial chylomicronaemia syndrome (FCS). FCS is a rare genetic disease that prevents the body from breaking down fats (lipids). Patients with this condition have extremely high levels of triglycerides in their blood. This causes [...]

2019-03-04T22:49:08+00:0005.03.2019|Drug Development Strategy, Regulatory Affairs|