FDA Monographs and Current Regulations for Sunscreen Products

  • August 8, 2019
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Over-the-counter (OTC) drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Currently, there are more than 300,000 OTC products on the market. Instead of reviewing each individual drug product, the FDA reviews the active ingredients and labeling of […] READ MORE...

Gene and Cellular Therapies: Five Keys to Regulatory Success

  • June 28, 2019
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Dr. Richard Crane, PhD Southwood Research, a ProPharma Group company We are living through a medical revolution. Advances in gene therapy, cell‑based therapies and tissue engineering offer real hope for patients with a range of debilitating diseases. The FDA, EMA and other global regulatory agencies are still learning how to evaluate the benefits and risks […] READ MORE...

The Unique Challenges of Gaining Approval for Drug-Device Combos

  • June 27, 2019
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A combination product is 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. Consider the asthma inhaler.  The primary mode of action (PMOA) is the drug because it’s the drug that’s providing the most […] READ MORE...

Why the FDA Should Never Be Your First Inspection

  • June 6, 2019
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You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products,and one of the best ways to accomplish that goal is by visiting facilities to determine whether they are compliant with FDA regulations. You never want the FDA to conduct the first inspection because […] READ MORE...

New GDUFA Rules: What Does It Take to Be Successful?

  • April 24, 2019
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GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022.  The continuing goal of the amendment is to facilitate timely access to high-quality, affordable generic drugs. Here are six things that Sponsors should do to significantly increase the chances of getting their ANDA submitted and approved under […] READ MORE...

How to Survive a Multi-Year Consent Decree

  • March 20, 2019
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Operating a business under a Consent Decree is extremely difficult; there is no area of the business that goes unaffected. In addition to fines that could reach $500 million, a three to five-year Consent Decree can result in additional penalties, remediation expenses, lost sales, and diminished stock value. That’s just the financial aspect. A Consent […] READ MORE...

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

  • February 13, 2019
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Getting through the process of compiling an ANDA and submitting it for approval is challenging. The application is termed “abbreviated” because applicants are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Still, applicants must scientifically demonstrate that their product performs in the same manner as the innovator […] READ MORE...

Year in Review: Taking a Look at Pharma’s Top News Stories & Events from 2018

  • January 9, 2019
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From FDA’s approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency’s submission requirements related to Sponsor meetings, it’s safe to say 2018 was a busy year for all of us.  As we look back on all that has happened throughout the year, […] READ MORE...

Outsourcing Functions Doesn’t Mean You’ve Outsourced Compliance Obligations

  • December 4, 2018
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Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic view, successful Sponsors understand the need to leverage the knowledge and resources that external specialist organizations bring to the table. Sponsors of every […] READ MORE...

How GDUFA II Impacts the Timing & Approval Process for Generic Drug Sponsors

  • November 6, 2018
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Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first enacted the Generic Drug User Fee Amendment (GDUFA I) in 2012. After negotiations between the FDA and industry representatives, and with input from public stakeholders, Congress mapped out the concept that generic drug sponsors would pay a user fee […] READ MORE...