How Working with a Consultant Improves Cost Efficiency, Speed, Completeness of Generic Applications

  • July 14, 2020
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An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once approved, the Sponsor may manufacture and market the generic drug product, and as a result of the Sponsor’s efforts, the public has access to a safe, […] READ MORE...

Understanding Cybersecurity Threats to Medical Devices

  • July 9, 2020
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The threat of cyber-attacks against medical devices is real. Medical devices capable of connecting, wirelessly, wired, or to portable media such as a USB drive, are more vulnerable to cybersecurity threats than unconnected devices. We now know that cyber-criminals can hack into medical networks through relatively simple means. Although there have been no documented cases […] READ MORE...

How Opioid Analgesic Drugs are Approved by the FDA

  • July 1, 2020
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The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasonings used by FDA officials to arrive at their final determination for specific regulatory decisions. To be approved for marketing, a drug must be safe and efficacious for its intended use. “Safe” is not […] READ MORE...

How Should You Respond & React When Employees Become Infected with COVID-19?

  • June 24, 2020
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FDA Outlines GMP Considerations for Manufacturers On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19.  The recommendations in the guidance document, entitled Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and […] READ MORE...

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...