Clinical Research Solutions
Indian API Manufacturer Fails to Correct Significant GMP Deviations, Receives FDA Warning Letter
In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility. During this inspection, the FDA investigator observed a number of significant deviations from...
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
#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
Multi-Regional Clinical Trials 102: Clinical Trial Design & Protocol-Related Issues
Additional information on the guidance document is available in our preceding FDA News article entitled "Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated...
Clinical Research Solutions
Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated with MRCTs
On Friday, September 9th, the FDA announced the availability of a draft guidance entitled “E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.” The draft guidance, which...
Clinical Research Solutions
FDA Embarks on Warning Letter “Rampage”
Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe. According to a recent article from Law360, the letters were...
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...