Biopharma / Pharma

//Biopharma / Pharma

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 [...]

96 New FDA 483s | May 21st 2018

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. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

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 [...]

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GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this week Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA published Among this later collection are the MHRA GCP Inspection Metrics Changes in the [...]

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices. [...]

GMP Regulatory Newsletter: Summary Scan | Week of 4/29/18

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA 4 from EMA 2 from Health Canada 2 items from Pakistan FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important. To see the complete list of laws, [...]

114 New FDA 483s | May 7th 2018

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. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them 1 warning letter went to an API manufacturer 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the outcome of [...]