In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more
Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall -
In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more
The Inflation Reduction Act of 2022 (the Act) includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health...more
On May 25, 2022, the U.S. Food and Drug Administration (FDA) issued a guidance document intended to help pharmacists and wholesale drug distributors understand and comply with its final rule regarding the import of certain...more
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more
Some Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation -
Lowering prescription drug pricing has been a hotly debated issue well before 2022 and is expected to continue in 2022. In November...more
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
Yesterday, the President issued an executive order (EO) on drug pricing for pharmaceuticals covered under Medicare parts B and D. The EO, in essence, proposes a form of price controls for drugs covered under Medicare parts B...more
Recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to Luminex Corporation. Luminex "manufactures microsphere-based and [polymerase chain reaction] PCR-based multiplexing systems for in-vitro...more
COVID-19, the disease caused by the SARS-CoV-19 virus, is complex, and the number, type, and severity of symptoms often vary from patient-to-patient. COVID-19 complications and outcomes can vary by age, the presence of...more
On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs
On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance on clinical trials of medical products during the COVID-19 pandemic, which provides general considerations to help sponsors assure the...more
U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more
3/9/2020
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs
Guidance Relevant for Purposes of Determining Orphan Drug Designation and Exclusivity. Finalizes Six Other Gene Therapies.
Two "hot" areas in drug development are i) gene therapies, and ii) therapies for orphan diseases....more
The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
12/20/2019
/ 510(k) RTA ,
FDA Approval ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pre-Market Notification ,
Premarket Approval Applications ,
Prescription Drugs ,
Regulatory Burden ,
Statutory Interpretation ,
Venture Capital
The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative medical therapies. An RMAT designation conveys significant regulatory...more
After being confirmed by the Senate in a 72-18 vote on December 12, 2019, the new Commissioner of the Food and Drug Administration (FDA) Dr. Stephen Hahn will be facing a number of critical issues on the immediate horizon...more