July 21, 2016
In our preceding FDA News article, we focused on the content of the first draft guidance, which addresses restrictions concerning the compounding of drug products that are essentially copies of...
July 12, 2016
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...
June 23, 2016
Additional information on FDA’s draft guidance is available in our preceding FDA News article, entitled “FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets,...
June 22, 2016
On Thursday, June 17th the FDA issued a draft guidance entitled “Quality Attribute Considerations for Chewable Tablets.”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...
June 21, 2016
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...
June 15, 2016
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...
May 16, 2016
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,...
April 26, 2016
In mid-April 2016, the FDA published a draft guidance clarifying the role of data integrity in current good manufacturing practice (cGMP) for drug products, as required under 21 CFR parts 210, 211,...
February 3, 2016
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...