Tag: Regulatory Agenda

United States | Roundup: Immigration Policies Update in Final Weeks of 2023

Federal agencies announced several important changes to immigration programs in the last two weeks of 2023, including the details of a new domestic visa renewal program, the extension of interview waiver authorities and premium processing fee hikes. For those who missed any of the announcements, here’s a roundup of key developments:

  • Domestic visa renewal: The State Department will allow a limited number of H-1B holders to renew their visas in the United States under a new pilot program, the details of which were published Dec. 21, 2023. The pilot will begin Jan. 29 and will be open to 20,000 H-1B visa holders whose previous visas were approved in certain time frames by U.S. visa processing posts in Canada and India. Read BAL’s full news alert here.
  • Interview waiver authorities: On Dec. 21, 2023, the State Department announced that it would extend interview waiver authorities for certain nonimmigrant visa applicants. Under the updated policy, which took effect Jan. 1, consular officers will have the authority to waive interviews for (1) first-time H-2 visa applicants and (2) other nonimmigrant visa applicants who were previously issued a nonimmigrant visa in any classification (other than a B visa) and are applying within 48 months of their most recent nonimmigrant visa’s expiration date. Applicants renewing a nonimmigrant visa in the same classification within 48 months of the prior visa’s expiration date continue to be eligible for an interview waiver as well. Read BAL’s full news alert here.
  • Premium processing fees: U.S. Citizenship and Immigration Services will increase premium processing fees on Feb. 26. Under a regulation published Dec. 28, 2023, premium processing fees will increase by about 12% to account for inflation. Read BAL’s full news alert here.
  • Schedule A input: On Dec. 20, 2023, the Department of Labor asked for public input on whether to revise its list of Schedule A job classifications that do not require permanent labor certification. Read BAL’s news alert here.
  • F and M student nonimmigrant classifications: USCIS issued policy guidance Dec. 20, 2023, regarding the F and M student nonimmigrant classifications, including the agency’s role in adjudicating applications for employment authorization, change of status, extension of stay and reinstatement of status for these students and their dependents in the United States. Find USCIS’ updated policy guidance here. Read BAL’s news alert here.

Additional Information: The Biden administration’s top regulatory priorities on employment-based immigration in 2024 include H-1B and H-2 modernization, fee hikes and changes to the green card process, according to the Department of Homeland Security’s regulatory agenda published in December.

©2023 Berry Appleman & Leiden. All Rights Reserved.
For more news on Immigration Policies Updated in 2023, visit the NLR Immigration section.

FDA 2018 Year in Review

The US Food and Drug Administration’s (FDA’s) 2018 regulatory agenda spurred significant activity throughout the year, including implementation of several initiatives and mandates required by the 21st Century Cures Act (Cures Act). FDA continues to take measures to reduce regulatory barriers to market entry for innovative products, and it is leveraging traditional administrative processes, such as the citizen petition process, to advance its policy goals, including increasing generic competition. FDA initiated targeted enforcement actions in areas of traditional focus, such as good manufacturing practice (GMP) compliance, but it also signaled renewed focus on tobacco advertising, unapproved stem cell procedures, and compounding. FDA also issued important guidance documents throughout 2018.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year and offers insight into the agency’s 2019 priorities and expected actions.

  1. Drugs

  2. Digital Health

  3. Drug Quality Security Act Implementation

  4. Drug Supply Chain Security Act

  5. Medical Devices

  6. Laboratory-Developed Tests and Precision Medicine

  7. Food

  8. Tobacco

  9. Cannabis

  10. Advertising and Promotion

  11. Clinical Investigations

  12. Manufacturing and Good Manufacturing Practice

  13. Enforcement

The Year Ahead

FDA’s activities and initiatives in 2018 suggest that 2019 will bring greater focus on data strategy; patient perspectives; and innovative ways to leverage data to influence product development, risk management and regulatory decisions. The agency’s focus on data may lead to greater emphasis and renewed focus on data integrity and data quality issues throughout the product lifecycle, from clinical research to manufacturing. The continued focus on novel products and new expedited review processes for digital health, regenerative therapies and novel devices may mean fewer barriers to market entry for novel products, but it may also mean more significant post-market data collection and surveillance requirements. Policy and regulatory initiatives on cybersecurity and interoperability suggest the possibility of increased enforcement and scrutiny of these issues in standard quality and cGMP inspections. While warning letters and other FDA enforcement actions remain static, the agency appears to be leveraging procedural and administrative processes to influence broader policy objectives in areas such as drug pricing and generic competition. Life sciences companies may benefit from greater flexibility regarding the use of data from nontraditional sources to drive product development, advertising and promotion and quality. They may also benefit from the availability of a number of means to engage in pre-development and pre-submission discussions with the agency.

 

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