Resources

Laws, Regulations, Guidance, and Concept Papers FDA published several new guidance, both draft and final, this week: 2 are administrative2 address quality1 addresses format for submission of vaccines dataBonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7. TGA published […]

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. [supsystic-tables id=7 ] Like This & Want More? Sign up to get […]

FDA posted 10 warning letters this week: Several for misbranded drugs2 in the drug area:1 for a finished drug manufacturer1 for a compounding pharmacy Note the FDA ‘requests’ that the firm must respond to. These always provide a roadmap for the type of activities expected of manufacturers who might find themselves with similar challenges. Free […]

Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week for guidance: The FDA published 6 documents.Nothing from EMA in the areas we follow.WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance. Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA […]

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. [supsystic-tables id=6 ] Like This & Want More? Sign up to get […]

Laws, Regulations, Guidance, and Concept Papers It’s been a slow week all around, perhaps spring breaks and the holidays? Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics. Enforcement A very slow enforcement week: FDA published only 2 warning letters.Nothing from Europe.We do see the usual collection of drug recalls and […]

Pleasanton, CA | April 9, 2018: FDAzilla, a global leader in FDA intelligence and analytics, announced the addition of Jamie Colgin as GCP Product Manager — further filling out its team of industry experts to include a GCP and data integrity professional. Jamie, hailing from Moorpark, CA and recipient of the prestigious Charles H. Butler Excellence […]

FDA posted 8 warning letters this week, including: 1 API manufacturer1 finished dosage form manufacturer2 compounding pharmacies DRUGS Keshiva Organics Pvt. Ltd (Maharashtra, India) received a warning letter dated March 15th 2018 based on the outcome of an inspection ending May 31st 2017. The firm is an API manufacturer. FDA identifies that inspections in 2011 […]

      A previous blog entry addressed the Office of Pharmaceutical Quality ‘One Quality Voice’ effort, an aspirational view of FDA’s efforts to ensure coordination in the review, inspection, and approval process as well as post-approval oversight of both facilities and products. Shortly after that publication, FDA’s Office of Product Quality published their first […]

Laws, Regulations, Guidance, and Concept Papers A slow week for guidance publication: 2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP […]