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March 17, 2020

Cipla Limited – 597511 – 02/25/2020

Delivery Method: VIA UPS Reference #: 320-20-26 Product: Drugs Recipient: Recipient Name Mr. Umang Vohra Recipient Title Managing Director and Global CEO Cipla Limited Cipla House, […]
March 17, 2020

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry

Submit Comments by 05/18/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
March 17, 2020

Compounding: Inspections, Recalls, and other Actions

| A | B | C | D | E | F | G | H | I | J | K | L | M […]
March 16, 2020

Natural Remedy Store Issues Voluntary Worldwide – Recall of Active Male Due to Presence of Undeclared Tadalafil

Summary Company Announcement Date: March 16, 2020 FDA Publish Date: March 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Undeclared Tadalafil […]
March 16, 2020

Applications Affected by the Reorganization of the Office of New Drugs

Applications The approved restructuring of the Office of New Drugs (OND) creates offices that align interrelated disease areas, and divisions with clearer and more focused areas […]
March 16, 2020

Emergency Investigational New Drug (EIND) Applications for Antiviral Products

Note: The following information is to be used by physicians who would like to request an Emergency IND for an antiviral product regulated by the Center […]
March 16, 2020

October – December 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen and hydrocodone bitartrate solution Medication error: inappropriate dosing schedule FDA is evaluating the need for regulatory action. Aimovig (erenumab-aooe) Hypertension FDA is evaluating the need […]
March 16, 2020

Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – 04/03/2020 – 04/03/2020

On This Page Date: April 3, 2020 Time: 10:00 AM – 1:00 PM ET This meeting will now be held via webcast only. The Food and […]
March 14, 2020

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

Docket Number: FDA-2020-D-1106 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Due to the Coronavirus Disease 2019 […]
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