Feb – Mar 2019
DEAR PHARMA PALS: The benefits of the drug should outweigh the risk. The exclusive on Risk Evaluation & Mitigation Strategies (REMS), based on the presentation by Stephen R. Auten, Partner, Taft Stettinius & Hollister LLP, at CPhI’s 7th Annual Pharma IPR Conference 2018, underlines this requirement.
REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
The purpose of REMS is to deduce the occurrence or severity of a particular serious adverse event. Once FDA determines a REMS is necessary, pharmaceutical manufacturers must develop, implement, and assess the specific REMS for their drug product.
FDA can require a REMS for prescription drugs or biologics if necessary to ensure that the benefits outweigh the risks. FDA can require a REMS for generics, but there are some different requirements. (REMS do not apply to over-the-counter (OTC) medications). Without a REMS, these medications would not be approved or would be withdrawn from the market because of known or potential serious risks associated with medication.
REMS may include interventions that support safe use. If a severe allergic reaction is possible, there may be conditions on administration, personnel, and equipment. Certain lab testing to be completed and the results are checked before a medication prescription is refilled. Those at high risk for an adverse event may not be prescribed the medication.
Any medications with REMS that have been removed from the market due to risks? None to date. FDA has not removed a drug with a REMS from the market due to new or serious issues that could not be mitigated by the REMS.
Exclusive
Risk Evaluation & Mitigation Strategies
Risk Evaluation and Mitigation Strategies (REMS) are required risk management plans that use risk minimization strategies beyond FDA-approved labeling to ensure that the benefits of certain prescription drugs outweigh their risks. REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with Read more…
Quality: From Compliance to Culture
Based on the presentation by Shashank Upadhye, Partner, Amin Talati Upadhye LLP, at CPhI’s 7th Annual Pharma IPR Conference 2018, organised by UBM India. Read more…
Quality: From Compliance to Culture
Dear friends in pharma space, having spent more than 30 years in pharma quality, through this publication I aim to create a general awareness on quality culture. I fully recognize that the content in this article is based on my views and there can be an alternate or contradictory view which may be equally valid. Read more…
Tech Article
How to prevent capping and lamination during tablet production
Anyone who has experienced capping or lamination during tablet production knows the frustration that comes from trying to diagnose the issue. Capping involves the upper or lower portion of the tablet separating horizontally, either partially Read more…
Review
11th ASIA PHARMA Expo 2019
The 11th ASIA PHARMA EXPO 2019, the largest and most international pharma exhibition ever in Bangladesh pharmaceutical industry, held from January 31 to February 2, 2019, at ICCB, Dhaka, was attended by 12,800+ trade visitors to explore the complete spectrum of latest pharma Read more…
Preview
P-MEC China 2019
P-MEC China 2019 will be held during 18- 20 June, 2019 at Shanghai New International Expo Center. The scale is expected to reach 70,000 sqm with 1000+ exhibitors in 2019, to create the strongest lineup in its history! Read more…
In Focus
The Life Engineering Imperative
One of the biggest issues worldwide, especially in emerging and developing markets, is access to affordable medicines. Often, countries chasing development goals focus on economic growth and improved trade numbers, leaving a large number of human development goals on the backburner. Sanitation, waste management, Read more…
Elesa+Ganter Tubular Handles
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type Read more…
Self-repairing doors for sterile environments
An increasing number of defined standards require reliable special doors for clean room application, for example in the pharmaceutical, medicine, biotechnology, aeronautical, electronics, automotive and process engineering areas. Specifying the correct door is one of the most important components in the clean room. Read more…
Regulars
India Pharma
The Union government-funded, Rs 150 crore Human Microbiome Project (HMP) will map trillions of microbes – bacteria, fungi, viruses, archaea – that are found in Indians, which will help uncover links to diseases. In a one-of-a-kind project in the country, researchers will
take skin and oral swabs and collect blood and faecal samples Read more…
Global Pharma
German-based Merck Group has been granted a patent for creating ‘crypto-objects’ based on artificial intelligence (AI) and blockchain that can be used to secure pharmaceutical supply chains. The patented system uses machine learning techniques to link physical objects to blockchain through unique identifiers, known as Read more…
Did You Know?
Mylan is the world’s second-largest manufacturer of generic drugs.
India is the world’s largest exporter of generic drugs, making almost 40 percent of all
new generics the FDA approved in 2018. Read more…
Tech News
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launch of services for new biological entities, called NBE Product Characterization. These services are offered by its subsidiary, Sartorius Stedim BioOutsource, an experienced, industry-leading contract testing organization based Read more…
