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1 Review of 2020 FDA Enforcement Activities
2 AGG Food and Drug Newsletter
3 FDA signals uptick in enforcement with market sweep on depression claims
4 FDA Withdraws Draft Guidance on CBD Enforcement
5 A Year in Review: FDA Enforcement in the Prescription Drug Advertising and Promotion World
6 FDA targets remdesivir, thymosin in compounding concerns
7 One of 7 on federal charges of selling misbranded drugs to stand trial in Nebraska
8 Coronavirus (COVID-19) Update: January 29, 2021
9 Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids
10 Three New Jersey food firms on notice from FDA because of import violations
11 Cannabis, CBD Sagas About to Get Real
12 HHS: Interagency Telepharmacy Fraud Enforcement Actions
13 FDA Waited 9 Months to Warn Public on Tianeptine
14 FDA CBD Regulations Put on Pause as New Administration Moves In
15 Dietary Supplement Executive Sentenced in Scheme to Fraudulently Sell Popular Dietary Supplements
16 Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k) Requirement
17 News Wrap: FDA says Johnson & Johnson vaccine is effective
18 FDA Steps Up Efforts to Protect Consumers from Food Allergens
19 Field Trip Health's New Psilocybin Research Facility Probes the Secrets of Shrooms
20 FDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks
21 Priorities for Healthcare and Life Sciences Enforcement in the Biden Administration
22 OPDP warns Paragard maker over promotional video
23 Missouri Bill Would Add MDMA, Psilocybin Mushrooms And LSD To Right-To-Try Law
24 OPDP warns AcelRx over Dsuvia promotional materials
25 Amendments to the FDA Laws try to Clarify and Improve Systems
26 Biden Administration's Expected Impact on Health Care and Life Sciences Enforcement
27 FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products
28 Transition From Trump To Biden Impacts Federal Hemp And CBD Rules
29 Wrap-Up of Federal and State Chemical Regulatory Developments, February 2021
30 Executive Sentenced in Alleged Fraud Scheme to Sell Diet Supplements
31 An Illegal Dietary Supplement Named Tianeptine Is Being Sold to Americans, and the FDA Knows It
32 Former Sales Representative Indicted in Compounded Prescription Drug Scheme
33 Officers and teachers 50-plus will soon be eligible for COVID-19 vaccines, Florida governor says
34 FDA tells Pfizer it doesn’t need to keep its vaccine at arctic temperatures
35 FDA allows storage, transport of Pfizer vaccine at higher temperatures
36 Third Time’s A Charm: Will California Finally Manage To Regulate Hemp-Derived Products?
37 Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers
38 The Latest on Pandemic Plot Twist
39 Georgia couple sentenced for importing and distributing male enhancement products and counterfeit goods from China as well as naturalization fraud
40 Lack of inspections, heavy metals cited in FDA enforcement updates
41 Some Pa. stores sell Delta-8 THC, which promises a weed-like high. Is it legal?
42 Federal judge bans enforcement of Joe Biden's 100-day deportation pause
43 Medical Marijuana For Kansas Proposed With Tight Rules In Hopes Of Winning Legalization
44 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
45 Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
46 Navigating FDA's Wave of Enforcement Discretion Policies: Device Availability in the Era of COVID-19
47 FDA Enforcement on Improper CBD Product Marketing
48 Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
49 CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes
50 COVID-19 IIE Dry Heat to Support Reuse of Certain Respirators
51 Digital Healthcare: Telehealth; Fitness Devices; AI
52 YF Spotlight: American educators search for common ground on school reopening
53 Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
54 Akari Therapeutics Presents New Preclinical Data Highlighting Potential of Long-Acting PASylated Nomacopan to Treat Retinal Diseases, Including Age-Related Macular Degeneration (AMD) and Uveitis
55 Expanding Criminal Enforcement Operations Globally to Protect Public Health
56 FDA Submits New CBD Enforcement Guidance To White House For Review
57 2020 at FDA: A Year of Unparalleled Contributions to Public Health
58 Eastern District Of New York Dismisses Putative Class Action Against Cannabis Operator For Failure To Plead Misrepresentation And Loss Causation
59 FDA delays enforcement of some DSCSA provisions by three years
60 FDA Recalls Enforcement Reports
61 FDA Inspection and Enforcement Developments During the COVID-19 Pandemic
62 Assessing Current FDA and DEA Enforcement of CBD Consumer Products and Market Outlook for 2021 and Beyond
63 Enforcement Policy for Providing UFI for Food Facility Registration
64 DA Inspections, Compliance, Enforcement, and Criminal Investigations
65 FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline
66 Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
67 How a Biden Administration Will Affect FDA’s Regulation of Medical Devices
68 Search FDA Warning Letters
69 Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
70 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
71 Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency
72 FDA's own documents reveal agency's lax, slow, and secretive oversight of clinical research
73 FDA continues to escalate enforcement for undeclared allergen recalls
74 FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance
75 FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities
76 FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products
77 FDA cites import violations in warning to Texas food firm
78 Coronavirus (COVID-19) Update: December 4, 2020
79 Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators
80 Exclusive: FDA enforcement actions plummet under Trump
81 Import Program – Food and Drug Administration (FDA)
82 FDA Warns Companies Illegally Selling CBD Products | FDA
83 FDA's COVID-19 Product Regulation Enforcement Roadmap
84 USRM Oral Argument in Appeal from FDA Enforcement Action
85 Six more months tacked onto regenerative medicine enforcement date
86 FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint
87 Better Data for a Better Understanding of Cannabidiol (CBD) Products
88 Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products
89 FDA Round-Up: Overview of Emergency Actions to Expedite the Availability of Medical Products to Combat COVID-19
90 Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
91 FDA releases enforcement policy for VTM and PBS/saline transport media during the COVID-19 pandemic
92 FDA Sends CBD Enforcement Policy to OMB, Issues Cannabis Clinical Research Draft Guidance, and Submits CBD Testing Report to Congress
93 HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval
94 Santa Ana officer pleads guilty to accepting $128,000 in bribes
95 Compliance Policy for the Quantity of Bioavailability and Bioequivalen
96 FDA issues enforcement policy for coronavirus transport media
97 CBD Industry Caught Between Regulators & Law Enforcement
98 FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges
99 FDA Extends UDI and Direct Marking Enforcement Discretion for Class I and Unclassified Devices to 2022
100 HHS pushes through last-minute policies impacting FDA