Drug Shortages Infographic

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FDA prioritizes drugs that are medically necessary. A medically necessary drug product is a product that is used to treat or prevent a serious disease or medical condition for which there is no alternative drug, available in adequate supply, that medical staff has determined to be an acceptable substitute. Although the agency focuses on medically necessary drugs, all potential shortages are evaluated to help determine the possible public health impact.

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AJA Pharmaceutical Industries Co. Ltd.

AJA Pharma has its own state of-the-art manufacturing plant, located in Hail Industrial City of Saudi Arabia. The plant is aimed to provide latest & highest standards of manufacturing services across the region. AJA Pharmaceuticals plant is capable to produce a wide range of pharmaceutical products in various finished dosage forms, thereby catering to the Contract manufacturing needs of our partners globally. We aim in AJA Pharma to enter into collaborations to co-Develop, co-Manufacture, co-Market and to widely sell and distribute carefully selected range of products as well as under license production projects with technology transfer; relying on the huge capabilities, highest quality and unique technologies we have in AJA Pharma Plant including the processing of lyophilized injectables to satisfy the ever-increasing market demands in our region and across the Globe.

OTHER ARTICLES

Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | March 20, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | March 20, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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Clinical Supply Availability & Speed to Study Start-Up

Article | March 20, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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Spotlight

AJA Pharmaceutical Industries Co. Ltd.

AJA Pharma has its own state of-the-art manufacturing plant, located in Hail Industrial City of Saudi Arabia. The plant is aimed to provide latest & highest standards of manufacturing services across the region. AJA Pharmaceuticals plant is capable to produce a wide range of pharmaceutical products in various finished dosage forms, thereby catering to the Contract manufacturing needs of our partners globally. We aim in AJA Pharma to enter into collaborations to co-Develop, co-Manufacture, co-Market and to widely sell and distribute carefully selected range of products as well as under license production projects with technology transfer; relying on the huge capabilities, highest quality and unique technologies we have in AJA Pharma Plant including the processing of lyophilized injectables to satisfy the ever-increasing market demands in our region and across the Globe.

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