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Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

FDA Law Blog

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. That can be incredibly informative. We’re doing this also through the inpatient portal because we were trying to get as much information in there as possible.

IT 120
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It It is critical for firms in a product distribution chain to be “recall ready.””.