FDA Enforcement News

Week of June 3rd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA warned 9 firms that operate a total of 53 websites to stop illegally marketing unapproved versions of opioid medications. FDA reminds the public that no one is authorized to sell or distribute opioids via the internet, with or without a prescription. A total of 17 warning letters were posted this week. We cover 3 of them below. DRUGS [...]

GMP Regulatory Newsletter: Summary Scan | Week of 6/3/18

Laws, Regulations, Guidance, and Concept Papers: A handful of guidance documents published this week from the FDA, EMA, and ICH. The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial [...]

Week of May 27th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA posted 6 warning letters this week, 3 of which address human drug manufacturers. Two of these 3 manufacture OTC drug products. We continue to provide the information that FDA requests firms to provide because this provides a roadmap for FDA expectations -- invaluable information for those firms that may find themselves with similar challenges. DRUGS: Jalco Cosmetic [...]

GMP Regulatory Newsletter: Summary Scan | Week of 5/27/18

Laws, Regulations, Guidance, and Concept Papers This was a short week in the US with the Memorial Day holiday on Monday: The FDA published 6 guidance documents WHO published 1 EMA didn’t publish any in the areas we monitor The non-guidance collection includes the usual from the FDA, EMA, MHRA, and HPRA this week Among the more important announcements [...]

Week of May 20th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 warning letters this week. Many were issued for unapproved new drugs/misbranding deficiencies. We address 4 below that focused on GMP deficiencies. CELLS/TISSUES: Emmett F. Branigan MD PS Inc (Bellingham, WA) received a warning letter dated May 7th 2018 based on the outcome of an inspection ending January 31st 2018. Though not stated directly, it appears that [...]

GMP Regulatory Newsletter: Summary Scan | Week of 5/20/18

Laws, Regulations, Guidance, and Concept Papers: FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011. EMA published 1 on IMPs for consultation. HPRA, WHO, Health Canada, and CDSCO each published 1. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence [...]

Week of May 13th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA published 4 warning letters this week: 2 were issued for unapproved new drugs 2 were issued to drug firms addressed below DRUGS: Ei LLC (Kannapolis, NC) received a warning letter on April 16th 2018 based on the outcome of an inspection ending October 6th 2017. Based on the nature of manufacturing and the identified deficiencies, it is interesting [...]

GMP Regulatory Newsletter: Summary Scan | Week of 5/13/18

Laws, Regulations, Guidance, and Concept Papers A lite week for new guidance publications:  2 each from FDA and EMA. Among the non-guidance publications are 2 of particular interest: 1st is a report of the drug approval times in the major health authority jurisdictions (including some nice graphs and figures) published by The Centre for Innovation in Regulatory Science. The [...]

Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April [...]