Blog


How to Ensure Your Device, Software, and Drug Are Ready for a Pre-Approval Inspection

  • August 31, 2020
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When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a manufacturing facility named in an application can manufacture the product, and that the submitted data are accurate and complete. Ultimately, the purpose of […] READ MORE...


What You Need to Know About the ICH

  • August 20, 2020
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The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices. To accomplish this goal, the FDA has partnered with regulatory bodies of several other countries to form the International Conference for Harmonisation of Technical […] READ MORE...


The Human Factor: Preparing Your Device for Usability Testing

  • August 13, 2020
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When it comes to usability studies, the focus should be on effectively preparing the device for use in humans. Whether a sponsor is conducting formative testing or validation testing, the “human factor” is the overriding concern; and, incorporating human factor data early on, and throughout the design process, can reduce the need for costly modifications […] READ MORE...


Bioequivalence and Product-Specific Guidances

  • July 22, 2020
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The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating the evidence needed to support ANDA approval. These guidances represent the Agency’s current thinking regarding generic drugs and describe expectations on how […] READ MORE...


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...