3 Factors to Consider in the Manufacturing Phase for Drug-Device Combination Products

  • June 17, 2020
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Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. An example of a […] READ MORE...

Pediatric Labeling Best Practices

  • June 10, 2020
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A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in inadequate therapeutic effect or actual harm. The patient potentially could be under or overdosed, which raises both efficacy and safety issues. For this reason, […] READ MORE...

Best Practices to Reduce Impurities in Generics

  • June 4, 2020
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Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After inspections of certain factories in China, Slovenia, and India, the FDA found that the recalled drugs contained cancer-causing impurities. Impurities are defined as substances inside a […] READ MORE...

Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic

  • May 27, 2020
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How Have the Regulations Changed Due to the Current Global Health Crisis and What Does This Mean for Medical Device Manufacturers in Europe? Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA.  Rather, medical device […] READ MORE...

Top 9 Failure Points During Nonclinical Drug Development

  • May 21, 2020
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The process of drug development involves clinical and nonclinical studies. Nonclinical studies are considered crucial for understanding the safety of new drugs. Before testing a drug in people, Sponsors must first understand whether the drug has the potential to cause serious harm to humans. Even though the FDA has detailed good laboratory practices (GLPs) for […] READ MORE...

FDA Works to Accelerate the Development of COVID-19 Treatments with New Guidance Documents

  • May 13, 2020
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On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19.  With these documents, the Agency intends to establish a more efficient process for submitting applications to initiate studies for new drugs and biological products, “and outline recommendations for ways to design clinical […] READ MORE...

Emergency Use Authorizations 101: COVID-19 Medical Devices

  • May 7, 2020
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Everything you Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from the COVID-19 pandemic justify “the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV).”  As such, […] READ MORE...

Now May be the Time to Approach the FDA Regarding CMC and Nonclinical Questions – Giving These Topics the Attention they Deserve

  • April 16, 2020
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Due to the current regulatory landscape that has been created by the COVID-19 pandemic, clinical trials have been disrupted across the globe.  To many Sponsors, this may feel like a loss of progress for your drug development program.  However, the current slowdown presents a great opportunity for Sponsors to approach the FDA regarding outstanding chemistry, […] READ MORE...

COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials

  • April 1, 2020
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As of March 27, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations and measures. Please note that information changes rapidly. Always check the applicable websites (EMA, FDA, Health Authority in your country, Inspectorate, etc.) […] READ MORE...

Ten Tips for Conducting Successful Virtual FDA Meetings in the Era of COVID-19

  • March 31, 2020
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The outbreak of COVID-19 (coronavirus) in the United States has significantly impacted our lives in virtually every way.  For pharmaceutical and medical device firms, one of these impacts came on March 10th when the FDA announced that all face-to-face meetings scheduled in March involving any division in the Agency’s Office of New Drugs (OND) would […] READ MORE...