Clinical Research Solutions

#7: Quality Systems Approach to Pharmaceutical CGMP Regulations

In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...

Clinical Research Solutions

#8: Special Protocol Assessment

The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...

Clinical Research Solutions

#10: Investigator Responsibilities – Protecting the Rights, Safety, & Welfare of Study Subjects

In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...

Clinical Research Solutions

FDA Addresses Extrapolating Adult Data for Pediatric Use

In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...

Clinical Research Solutions

Tobacco Final Rule: Advice for Manufacturers

On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...

Clinical Research Solutions

FDA Works to Reduce Medical Errors, Part One: Background & Overview of FDA’s Proprietary Naming Guidance

In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...

Clinical Research Solutions

Regulatory Specialists & Project Managers

Job Description The Weinberg Group, the leading FDA consultancy, is growing and looking for regulatory professionals of all levels to join our staff. Successful candidates will have at least a...

Clinical Research Solutions

Business Development Associate

Job Description Great opportunity for someone looking to launch their career in the sales or administrative fields! Prior experience is not required, but may be helpful. The Weinberg Group, the...

Clinical Research Solutions

CMC Specialist

Job Description The Weinberg Group, the leading FDA consultancy, is expanding and seeking an experienced CMC professional to add to our existing capabilities. Qualified candidates must have at least...

Clinical Research Solutions

Cybersecurity in Medical Devices: Definitions from FDA's Draft Guidance

Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...

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