Resources

Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues Read the full article here. Original Source: https://www.raps.org/news-and-articles/news-articles/2019/4/scope-of-fda-draft-guidance-on-nonbinding-feedback

When it comes to scanning 483 observations, can a 15-second search replace hours (or weeks) of research and still provide enough data? Yes, and more. Using AI technology and human expertise, the process of researching enforcement and observation trends has become efficient and effective. The Old Way of Researching Combination Products Before the introduction of […]

This week FDA posted 11 warning letters to dietary supplement manufacturers, one issued regarding tobacco, two to pharma firms, and one to a compounding pharmacy. We cover the last three here. DRUGS | Luen Fook Medicine Sdn. Bhd. Luen Fook Medicine Sdn. Bhd. (Singapore) received a warning letter on April 4, 2019 based on the outcome […]

Govzilla and FOI Services announced Tuesday, April 16th, 2019 the beginning of their official partnership that integrates FOI Services’ unique and vast dataset with Govzilla’s innovative analytics tools to help solve regulatory intelligence problems. FDA regulated industries’ need for immediate access to enforcement documents is growing as more companies expand their markets and supply chains […]

Enforcement was slow this week. No drug or medical device GMP warning letters were issued except for two to compounding pharmacies, a rarity. We cover those two here. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago. COMPOUNDING PHARMACY | Apollo Care LLC Apollo Care LLC […]

Enforcement in terms of warning letter posting was busy this week. Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years (you can find the FDA press release here). Lachman Consultants released their perspective last week. In addition, there were another two to drug product […]

FDA posted 9 warning letters this week. This included two to pharmaceutical firms and two to compounding facilities. We cover these four below. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago. DRUGS | Mariposa Labs LLC Mariposa Labs LLC (Boise, ID) received a warning […]

Recently, the CDER warning letter issuance skyrocketed from 70 in FY2014 to 128 in FY2018, an increase of 83%. What types of firms are taking the heat? And where are they located? Here we answer these questions and more with a review of CDER warning letter trends in regard to facility type, including: Year-over-year analysis […]

We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies. DEVICE | TEI Biosciences Inc. TEI Biosciences Inc. (Plainsboro, NJ) received a warning letter on March 6, 2019 based on the outcome of […]

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. Lupin announced that they received a warning letter, but it has not been posted by the FDA yet. […]