At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising key questions about its...more
10/6/2025
/ Abbreviated New Drug Application (ANDA) ,
Comment Period ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Reform ,
Supply Chain
On September 24, 2025, the U.S. Food and Drug Administration (FDA) held a joint town hall with the Partnership for DSCSA Governance (PDG) about the impending expiration of the large dispenser exemption under the Drug Supply...more
10/6/2025
/ Contract Terms ,
Data-Sharing ,
Distributors ,
DSCSA ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Public Meetings ,
Regulatory Requirements ,
Section 340B ,
Supply Chain
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more
On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more
On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next steps in the regulatory process to import...more
In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and...more
On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development and assessment of applications for...more
The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that provides a one-year reprieve from certain...more
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more
The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection,” which, if finalized, would expand...more
On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more
Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to provide...more
On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more
On May 19, the U.S. Food and Drug Administration (FDA or the Agency) published the draft guidance “Risk Management Plans to Mitigate the Potential for Drug Shortages,” which aims to assist drug manufacturers in complying with...more
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for the importation of unapproved finished...more
The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more
Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly...more
On 9 July 2021 President Biden signed a far-reaching executive order intended to promote competition in the American economy. The order targets perceived corporate consolidation and anticompetitive activity in the labor,...more
Pursuant to Executive Order 14017, issued by President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in America’s supply chains for semiconductor manufacturing and advanced packaging,...more
6/11/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Executive Orders ,
Goods or Services ,
Manufacturers ,
Minerals ,
Pharmaceutical Industry ,
Semiconductors ,
Supply Chain ,
Unfair or Deceptive Trade Practices ,
USTR
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI). ...more
On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more
In last week's Federal Register, the U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021. This Federal Register Notice announces...more
On February 2, Hogan Lovells partners Melissa Bianchi, David Horowitz, and George Ingham presented a webinar to the Biotechnical Innovation Organization (BIO) on “What Biotech Employers Need to Know about COVID Vaccines and...more
2/16/2021
/ Biotechnology ,
Coronavirus/COVID-19 ,
Disability Discrimination ,
Employee Rights ,
Employer Liability Issues ,
Employment Policies ,
Health and Safety ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Vaccinations ,
Workplace Safety