FDAImports.com

FDA, USDA, and Customs regulation, import, export, labels, labeling review, all commodity requirements and more for international and domestic companies.

[FDAImports.com @fdaimports]

@blenglandllc is proud to announce obtaining the successful modification of a CBP WRO that banned the Smart Glove Group’s disposable gloves manufactured in Malaysia from entry into the U.S. due to forced labor concerns. https://t.co/ifLCO4kiY7

[FDAImports.com @fdaimports]

Yesterday, @fdaimports sister law firm, @blenglandllc, announced its attorneys and regulatory staff will join OFW Law on May 1st! We will continue to operate separately, providing the same regulatory services as we have for over 15 years. https://t.co/nx869jau4D

[FDAImports.com @fdaimports]

FDA has begun notifying food facilities that failed to comply that their registration has been canceled. Any facility that received this email should take action to confirm the information on their facility registration is consistent with the DUNS database
https://t.co/xr4t6xoVoY

[FDAImports.com @fdaimports]

FDA withdrew approval of 11 abbreviated new drug applications (ANDAs)

https://t.co/skOD0PFypr

[FDAImports.com @fdaimports]

FDA announced a discussion paper soliciting public comments on advanced manufacturing technologies. The paper presents policy development identified by CDER scientific and policy experts associated with AI to pharmaceutical manufacturing.

https://t.co/nrMCPLkYDQ

[FDAImports.com @fdaimports]

FDA is requesting nominations for voting members to serve on the Patient Engagement Advisory Committee in the Center for Devices and Radiological Health.

https://t.co/jeVLlmSU9B

[FDAImports.com @fdaimports]

FDA filed a petition, submitted by Innophos, Inc., proposing that the color additive regulations be amended to provide for the safe use of tricalcium phosphate in poultry, icing, white chocolate candy melts, doughnut sugar, and sugar for coated cadies.
https://t.co/L12TkczDY7

[FDAImports.com @fdaimports]

FDA announced a draft guidance entitled “Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.” This provides recommendations to sponsors developing drugs intended to treat neovascular age-related macular degeneration.
https://t.co/z3IzdDcEUD

[FDAImports.com @fdaimports]

FDA announced an opportunity for public comment on the proposed collection of information associated with current good manufacturing practice (CGMP) for blood and blood components related to reducing the risk of transfusion-transmitted infection (TTI).

https://t.co/d9xgAkcUCY

[FDAImports.com @fdaimports]

#SENA23 begins on Sunday! If you are going to be at the show, stop by Booth 769 or come check out Ben England and Jessica Rifkin discuss "Customs Compliance and Enforcement: Forced Labor and the UFLPA" with CBP officials. We hope to see you there!

[FDAImports.com @fdaimports]

FDA announced an opportunity for public comment on the proposed collection of information associated with medical device premarket notification (510(k)).

https://t.co/9FuKMW9bks

[FDAImports.com @fdaimports]

In late February 2023 and in response to a growing number of non-compliant devices being imported and sold in the United States, EPA issued a concise Compliance Advisory notice for pesticide devices. Find out more about this Advisory here: https://t.co/ocYAJhwZcG

[FDAImports.com @fdaimports]

FDA recently released guidance document Q13, which outlines the agency's recommendations for continuous manufacturing of drug substances and drug products for chemical entities and therapeutic proteins. If you have questions, please call 410-220-2800. https://t.co/1EcOB1OKIt

[FDAImports.com @fdaimports]

One week from Today @SeafoodExpo_NA 2023 will be in full swing! We would love to see you at Booth 769!

We are ready to answer your questions about getting products released, Import Alerts, Prop 65 violations, managing Customs seizures, and more. #SENA23

[FDAImports.com @fdaimports]

FDA withdrew the compliance policy guide (CPG) Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power -- the CPG identified this notice contains policies that have been superseded by a subsequent FDA action.

https://t.co/H1r0WiX3cZ

[FDAImports.com @fdaimports]

FDA made available the draft guidance “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.” This guidance provides information on requesting and conducting PSG meetings with FDA.
https://t.co/qmIW30JgMH

[FDAImports.com @fdaimports]

Last Chance to Register! Join us and @Impactt_Limited for:
Insider Tips: Navigating Customs Forced Labor Compliance and Enforcement

February 28, 12 pm EST| https://t.co/hPuqgM1Rm2
#forcedlabor #WROs #supplychaintraceability

[FDAImports.com @fdaimports]

FDA's guidance, “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act," outlines its enforcement priorities for compounding certain ibuprofen products.
https://t.co/s5FudXCmTM

[FDAImports.com @fdaimports]

Come see us at @SeafoodExpo_NA! We will be at booth 769 March 12-14! On March 13 at 11:45, Ben England will be moderating and Jessica Rifkin will be discussing "Customs Compliance and Enforcement: Forced Labor and the UFLPA" with CBP! #SENA23 https://t.co/iRcDTN1prz

[FDAImports.com @fdaimports]

Want to understand more about what Ben England, Jessica Rifkin and our friends at @Impactt_Limited will be discussing on February 28? Read our latest blog regarding what “Insider Tips: Navigating Customs Forced Labor Compliance and Enforcement” will cover. https://t.co/9tgZ6VvVYE