Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more
On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When...more
On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug...more
The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any recommendation that...more
The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we summarized online here. In the article below, we...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more
With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more
8/26/2021
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Induced Infringement ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI)....more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more
10/29/2020
/ CAFC ,
Carve Out Provisions ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
GlaxoSmithKline ,
Orange Book ,
Patent Infringement ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more
10/20/2020
/ China ,
Generic Drugs ,
Hatch-Waxman ,
Innovation ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Recently, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced policies intended to permit the importation of, and Medicaid reimbursement for, certain foreign prescription...more
On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
7/15/2020
/ Affordable Care Act ,
Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Severability Doctrine ,
Tax Cuts and Jobs Act ,
Trump Administration
The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. ...more
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
...more
3/25/2020
/ Adverse Events ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Regulatory Oversight ,
REMS
During the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) expects that workforces will be reduced at the same time that the use of medical products will increase....more
On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable...more
On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications -
On 28 March China's National Medical Products Administration (NMPA) published a list of an...more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
2/22/2019
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Agenda ,
Regulatory Oversight ,
Reversal
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
12/28/2018
/ Center for Drug Evaluation and Research (CDER) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Trump Administration
On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more