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April 10, 2020

A Perspective on the FDA’s COVID-19 Response

Image By: Mitch Zeller, Director, FDA Center for Tobacco Products I have the honor to run the FDA’s Center for Tobacco Products (CTP). While CTP’s work […]
April 10, 2020

Earthley Wellness dba Modern Alternative Mama LLC – 606525 – 04/09/2020

Product: Drugs Recipient: Earthley Wellness dba Modern Alternative Mama LLC 240 Outerbelt Street, Suite #8Columbus, OH 43213United States Date:               April 9, 2020 RE:                 Unapproved […]
April 9, 2020

Manufacturing, Supply Chain, and Drug Inspections | COVID-19

On this page  FDA has guidance on how to implement manufacturing and site changes, as well as reporting to the application, listed in references below. Manufacturing and […]
April 9, 2020

Stakeholder Engagement | COVID-19

FDA is committed to continued engagement with patients, pharmacists, physicians, and healthcare professional organizations, as well as other stakeholders, to address the critical public health crisis […]
April 9, 2020

CPG Sec. 450.550 Control and Accountability of Labeling Associated with Tamper-Resistant Packaging of Over-the-Counter Drug Products

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Final rules (21 CFR 211.132) were published in […]
April 9, 2020

CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: *Requirements of the tamper-resistant packaging (TRP) regulations covering […]
April 9, 2020

CPG Sec. 450.200 Drugs – General Provisions and Administrative Procedures for Recognition as Safe and Effective

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND AND POLICY: An OTC drug listed in subchapter […]
April 9, 2020

CPG Sec. 430.200 Repacking of Drug Products – Testing/Examination under CGMPs

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Questions have periodically arisen regarding how various testing […]
April 9, 2020

CPG Sec. 425.500 Computerized Drug Processing; Identification of “Persons” on Batch Production and Control Records

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Section 211.188(b)(11) of the Current Good Manufacturing Practice […]
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