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FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. “Today’s approval provides an additional treatment option for patients with [...]

2019-11-19T20:23:22+00:0019.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This [...]

2019-11-19T20:18:34+00:0019.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC [...]

2019-11-19T20:12:46+00:0019.11.2019|Pharmacovigilance, Regulatory Affairs|

Infarmed: Revisão da lista de medicamentos abrangidos pela notificação prévia de exportação ou distribuição para outros Estados-membros

Foi publicada a Deliberação n.º 095/CD/2019, de 11 de novembro, que veio atualizar a lista de medicamentos cuja exportação ou distribuição para outros Estados-membros da União Europeia carece de prévia notificação ao Infarmed. Esta Deliberação entra em vigor no 3.º dia útil seguinte ao da sua publicação, ou seja, no próximo dia 14 de novembro. No [...]

2019-11-17T20:46:37+00:0018.11.2019|Regulatory Affairs|

EMA: Regulators’ advice can make a difference for faster patient access to highly innovative therapies

Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative therapies that address unmet medical needs. The chair of EMA’s committee for advanced therapies (CAT), Martina Schussler-Lenz, the chair of EMA’s human medicines committee [...]

2019-11-17T20:38:42+00:0017.11.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Revogação da suspensão da autorização de distribuição por grosso de medicamentos de uso humano (Medlog Logistica Farmacêutica, SA)

O Conselho Diretivo deliberou revogar a Deliberação n.º 87/CD/2019 e, deste modo, levantar a suspensão da autorização para o exercício da atividade de distribuição por grosso n.º A020/10/H/002/2017 concedida à sociedade Medlog, Logística Farmacêutica, SA, com instalações sitas na Zona Industrial de Alcochete, distrito de Setúbal, com fundamento no cumprimento do prazo de suspensão aplicado, [...]

2019-11-17T20:15:39+00:0017.11.2019|Regulatory Affairs|

FDA approves first therapy to treat patients with rare blood disorder

Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. “When patients receive multiple blood transfusions, there is a risk for iron overload, which can affect many organs,” said [...]

2019-11-17T20:10:54+00:0017.11.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed: Publicado “Regulamento de gestão da disponibilidade do medicamento”

O Regulamento de gestão da disponibilidade do medicamento foi aprovado - através da Deliberação N.º 93/CD/20019 que o anexa - e encontra-se já disponível na área Gestão da disponibilidade do medicamento. Este regulamento tem como objeto a fixação de regras e procedimentos para gerir a disponibilidade do medicamento, designamente no que se refere às notificações de faltas ou [...]

2019-11-14T21:17:31+00:0014.11.2019|Regulatory Affairs|

FDA Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two [...]

2019-11-13T21:22:57+00:0013.11.2019|Pharmacovigilance, Regulatory Affairs|

Infarmed: Produtos sem finalidade médica com enquadramento regulamentar como dispositivos

O Regulamento (UE) 2017/745 do Parlamento Europeu e do Conselho, de abril de 2017 é aplicável, não só a dispositivos médicos, mas também a produtos para os quais o fabricante alegue unicamente fins estéticos ou outros fins não médicos, mas que sejam muito semelhantes a dispositivos médicos em termos de funcionamento e de perfil de risco. São [...]

2019-11-13T21:18:26+00:0013.11.2019|Regulatory Affairs|

FDA Statement on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, [...]

2019-11-08T17:37:19+00:0008.11.2019|Quality System and Audit, Regulatory Affairs|

FDA: Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also [...]

2019-11-06T22:17:44+00:0006.11.2019|Regulatory Affairs|

EMA encourages companies to submit type I variations for 2019 by end of November 2019

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2019 no later than Friday 29 November 2019. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23 December 2019 and 6 January 2020 and within the 30-day timeframe set out in Article [...]

2019-11-06T22:01:37+00:0006.11.2019|Regulatory Affairs|

Infarmed: Suspensão de autorizações de distribuição por grosso de medicamentos de uso humano

O Infarmed suspendeu a autorização para o exercício da atividade de distribuição por grosso de medicamentos de uso humano das seguintes entidades: Medivip - Distribuição De Produtos Farmacêuticos, Lda. (Autorização N.º A019/12/H/003/2019, de 2019-04-03), com armazém sito em Rua da Bica, n.º 15, Edifico Vipfarma I e II, Ninho do Mocho – Quinta do Estrangeiro, [...]

2019-11-04T22:10:57+00:0004.11.2019|Quality System and Audit, Regulatory Affairs|

FDA Statement on concerns with medical device availability due to certain sterilization facility closures

As the agency responsible for ensuring the safety and effectiveness of all medical devices, the U.S. Food and Drug Administration has been closely monitoring the supply chain effects of closures and potential closures of certain large-scale sterilization facilities that use a gas called ethylene oxide to sterilize medical devices prior to their use. The recent closure of [...]

2019-11-03T22:01:41+00:0003.11.2019|Pharmacovigilance, Regulatory Affairs|

EMA: Dialogue with Chinese authorities on medicine regulation

The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals. Topics for discussion between Guido Rasi, EMA's Executive Director, Andrzej Rys, Director responsible for Health Systems, Medical Products and [...]

2019-11-03T21:06:23+00:0003.11.2019|Regulatory Affairs|

FDA Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives to approved prescription and nonprescription products and are widely available in the marketplace. Homeopathic products, however, are marketed [...]

2019-11-03T21:20:41+00:0003.11.2019|Pharmacovigilance, Regulatory Affairs|

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s [...]

2019-10-30T21:49:57+00:0030.10.2019|Pharmacovigilance, Regulatory Affairs|

FDA approves new breakthrough therapy for cystic fibrosis

The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which [...]

2019-10-30T21:45:16+00:0030.10.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Enhancing consistency in wording of therapeutic indications to support healthcare decision-making

EMA’s human medicines committee (CHMP) has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines. The document is intended to guide assessors in the national competent authorities who are responsible for evaluating marketing authorisation and extension of indication applications received by EMA. It outlines key elements that assessors should consider when evaluating the therapeutic indications proposed by the applicant, for example, whether [...]

2019-10-27T21:00:21+00:0027.10.2019|Regulatory Affairs|