FDA Enforcement News

19 03, 2018

CDRH Planned Reorganization Breaks Down Silos and Focuses Expertise by Product Type

By | 2018-03-19T16:02:55+00:00 March 19th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Enforcement Trends, FDAzilla, Medical Devices|

The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns the expertise into teams by product type and technology.  Individuals from the evaluation and compliance groups for specific product types and technologies will now be on one [...]

16 03, 2018

Week of Mar 4th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-03-16T16:03:32+00:00 March 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspections, FDA Warning Letters, FDAzilla|

FDA posted six new warning letters this week including one to a compounding pharmacy and two to finished drug manufacturers. Both finished drug manufacturers are located outside the US. We address those below. Finished Drug Manufacturers: Zhejiang Ludao Technology Co., Ltd (Taizhou, China) received a warning letter on February 23th 2018 based on the outcome of an inspection ending [...]

13 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/4/18

By | 2018-03-13T12:14:07+00:00 March 13th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It was a light week on the guidance front particularly from the EMA and the FDA. On the other hand: WHO published two drafts. Health Canada published a final revision to their drug GMPs. And, perhaps more important than all (I admit I’m prejudiced on the topic), is the final version of the [...]

6 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/25/18

By | 2018-03-06T12:39:19+00:00 March 6th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers FDA published four guidance documents this week: Two that address implementation of drug track and trace activities Two that focus more on medical and safety The EMA published one item focused on inclusion of excipients in labeling. The non-guidance set of publications includes items from the EMA, FDA, MHRA, CDSCO, and TGA. Also [...]

1 03, 2018

The Semler Complaint Against the FDA

By | 2018-03-01T16:17:40+00:00 March 1st, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspection Stories, FDAzilla|

Semler Research Center Private Limited (Bangalore, India) is suing the FDA for requiring that sponsors repeat BA/BE studies based on the outcome of an FDA inspection that raised concerns about the trustworthiness and correctness of data. The legal complaint was filed January 18, 2018, in the US District Court Central District of California. The firm seeks $50,000,000 damages and a jury [...]

27 02, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/18/18

By | 2018-02-27T12:14:29+00:00 February 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front. To see the complete list of laws, regulations, guidance, and concept papers published this week, [...]

21 02, 2018

Generic Drug Application Submission and Assessment

By | 2018-02-21T16:21:20+00:00 February 21st, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Enforcement News|

The FDA published two related guidance for generic drugs in January:  the 11-page MAPP 5241.3 titled 'Good Abbreviated New Drug Application Assessment Practices' and a 30-page heavily footnoted draft guidance titled ‘Good ANDA Submission Practices.’  Both contribute to the ‘Drug Competition Action Plan’ that is developed to increase drug competition with the production and approval of high-quality generic drugs. [...]

11 01, 2018

The End of Homeopathic Products’ Free Pass

By | 2018-02-12T14:35:05+00:00 January 11th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, Pharma - Featured|

Homeopathic Products:  What Are They and Why Should You Care? by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Among the unique enforcement actions in fiscal year 2017 are a cluster of warning letters and recalls of homeopathic products.  2017 saw as many warning letters issued to these firms as were issued between 2009 and 2013.  This is a [...]