Clinical Research Solutions
FDA Issues Warning Letter to Chinese API Manufacturer After Lying to the Agency During Inspection
Late last month, FDA released a warning letter that had been sent to Xiamen Pharmaceutical Co., Ltd., outlining a number of “significant deviations from current good manufacturing practice (CGMP) for...
Clinical Research Solutions
EMA Recommends Suspension of Numerous Drugs Due to Faulty Testing
On Friday, July 22nd, the European Medicines Agency (EMA) recommended the suspension of hundreds of drugs that had undergone bioequivalence testing at Semler Research Centre Private Ltd., a clinical...
Clinical Research Solutions
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In our preceding FDA News article, we focused on the content of the first draft guidance, which addresses restrictions concerning the compounding of drug products that are essentially copies of...
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...
Regulatory Sciences
FDA Draft Guidance When Developing Chewable Tablets, Part Two
Additional information on FDA’s draft guidance is available in our preceding FDA News article, entitled “FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets,...
Clinical Research Solutions
FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets, Part One: Introduction & Overview
On Thursday, June 17th the FDA issued a draft guidance entitled “Quality Attribute Considerations for Chewable Tablets.”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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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,...
Clinical Research Solutions
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,...