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Submission: On January 22 via manual from US — Scanned from DE
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* Skip to main content * Skip to FDA Search * Skip to in this section menu * Skip to footer links An official website of the United States government Here’s how you know The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials Topic Paragraphs DON'T DELAY, GET YOUR COVID-19 VACCINE OR BOOSTER TODAY! Getting vaccinated or receiving a booster if you’re already vaccinated is the best thing you can do to help protect yourself, family and friends. Vaccines.gov Featured FDA COVID-19 RESPONSE FDA is working with U.S. government partners, including CDC, and international partners to address the pandemic. FDA 2021 YEAR IN REVIEW - WORKING FOR YOU Click here to view the Acting Commissioner's report PRODUCTS WE REGULATE FOOD DRUGS MEDICAL DEVICES RADIATION-EMITTING PRODUCTS VACCINES, BLOOD, AND BIOLOGICS ANIMAL AND VETERINARY COSMETICS TOBACCO PRODUCTS FEATURED TOPICS NEW ERA OF SMARTER FOOD SAFETY A new approach to food safety that recognizes and builds on the progress made in the past but looks towards what processes and tools will be needed for the future. FOSTERING DRUG COMPETITION Increasing the availability of generic drugs helps to create competition in the marketplace, helping make treatment more affordable and increasing access to healthcare for more patients. COMBATING THE OPIOID CRISIS FDA takes actions to combat prescription opioid abuse. RECENT PRESS ANNOUNCEMENTS Jan 21 FDA TAKES ACTIONS TO EXPAND USE OF TREATMENT FOR OUTPATIENTS WITH MILD-TO-MODERATE COVID-19 Jan 21 FDA ROUNDUP: JANUARY 21, 2022 More Press Announcements Newsroom Meetings Testimony Speeches RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS The FDA provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this website Jan 19 AMY’S KITCHEN VOLUNTARILY ISSUES ALLERGY ALERT ON UNDECLARED MILK IN A SINGLE LOT OF VEGAN ORGANIC RICE MAC & CHEEZE Food & Beverages Jan 19 BCS INTERNATIONAL CORP. ISSUES ALERT ON UNDECLARED SULFITES IN “DR. SNACK GOJI BERRY” Food & Beverages Jan 19 FROZEN FOOD DEVELOPMENT RECALLS LIDL BRANDED CHOPPED SPINACH BECAUSE OF POSSIBLE HEALTH RISK Food & Beverages More Recalls Market Withdrawals & Safety Alerts Subscribe to the Enforcement Report Mailing List Paragraph Header FDA VOICES: PERSPECTIVES FROM FDA EXPERTS WHAT FDA’S FOODS PROGRAM ACHIEVED IN 2021 TO PROTECT CONSUMERS AND THE FOOD SUPPLY Despite the unprecedented challenges we’ve all faced during the COVID-19 pandemic, 2021 was another important year for FDA's Foods Program. MANY IMPORTANT DRUGS APPROVED IN 2021 AS COVID-19 PANDEMIC CONTINUES CDER approved a wide variety of safe and effective new drug therapies in 2021 despite challenges brought on by the ongoing COVID-19 pandemic. LOOKING AHEAD TO 2022 AS FDA’S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MANAGES A SUSTAINED INCREASE IN WORKLOAD While CDRH’s response to the pandemic remains a top priority, we anticipate a gradual transition back toward normal review timelines in 2022. More FDA Voices RECENTLY PUBLISHED GUIDANCES Jan 21 TECHNICAL SPECIFICATIONS FOR SUBMITTING CLINICAL TRIAL DATA SETS FOR TREATMENT OF NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) Drugs Jan 21 DIGITAL HEALTH TECHNOLOGIES FOR REMOTE DATA ACQUISITION IN CLINICAL INVESTIGATIONS Drugs Jan 21 CVM GFI #159 (VICH GL36) STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: GENERAL APPROACH TO ESTABLISH A MICROBIOLOGICAL ADI Animal & Veterinary FDA Guidance Search RESOURCES AND PROGRAMS JOBS AT FDA INSPECTIONS AND COMPLIANCE MEDWATCH: SAFETY ALERTS SCIENCE & RESEARCH FDA ORGANIZATION IMPORT PROGRAM WARNING LETTERS COMBINATION PRODUCTS WHAT DOES FDA REGULATE? CRIMINAL INVESTIGATIONS DISPOSAL OF UNUSED MEDICINES EMERGENCY PREPAREDNESS Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. 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