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Quality & Compliance GMP

July 21, 2016

FDA Outlines Policies for Compounding Drug Products That Are Essentially Copies of Approved Drugs Under Section 503B of the FD&C Act

In our preceding FDA News article, we focused on the content of the first draft guidance, which addresses restrictions concerning the compounding of drug products that are essentially copies of...

Quality & Compliance GMP

July 12, 2016

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...

Quality & Compliance Agency Alerts

June 23, 2016

FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets, Part Two: FDA’s Recommendations

Additional information on FDA’s draft guidance is available in our preceding FDA News article, entitled “FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets,...

Quality & Compliance GMP

June 22, 2016

FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets, Part One: Introduction & Overview

On Thursday, June 17th the FDA issued a draft guidance entitled “Quality Attribute Considerations for Chewable Tablets.” The document “describes the critical quality attributes that should be...

Quality & Compliance GMP

June 21, 2016

Whole Foods Receives Warning from FDA for Numerous Violations at Manufacturing Facility

On Wednesday, June 8th, the FDA issued a warning letter to Whole Foods Markets Inc., citing the company’s Everett, Massachusetts manufacturing facility for several GMP violations. The violations...

Quality & Compliance GMP

June 15, 2016

FDA Releases Guidance on Nonclinical Studies for Osteoporosis Drugs

On June 13, FDA released a new pharmacology/toxicology guidance providing guidance on nonclinical studies to support the approval of drugs intended for the treatment of osteoporosis. This guidance...

Quality & Compliance Agency Alerts

May 16, 2016

FDA Warns of Serious Side Effects Associated with Fluoroquinolone Antibacterial Drugs

On Thursday, May 12th, the FDA issued a warning regarding fluoroquinolone antibacterial drugs, stating that the associated side effects “generally outweigh the benefits for patients with sinusitis,...

Quality & Compliance GMP

April 26, 2016

FDA Draft Guidance Addresses Increase in Data Integrity Violations

In mid-April 2016, the FDA published a draft guidance clarifying the role of data integrity in current good manufacturing practice (cGMP) for drug products, as required under 21 CFR parts 210, 211,...

Quality & Compliance GMP

February 3, 2016

FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program

On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...

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