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Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.”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

HHS Names the First 10 Drugs for Medicare Price Negotiation

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

Prescription Drug Provisions in the Inflation Reduction Act of 2022

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

FDA Issues Guidance on Importing Drugs from Canada

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

CDER Launches the ARC Program to Expedite Treatment Options for Rare Diseases

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

FDA Warns Companies Illegally Selling CBD and Delta-8 THC Products

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

Prescription Drug Provisions in the Build Back Better Act

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

HHS Shuts Down FDA's Unapproved Drugs Initiative

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

Administration Issues Executive Order on Medicare Drug Pricing Which Attempts to Impose Price Controls on Drugs Purchased by the...

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

Patient Dies, and the FDA Issues Warning Letter to In-Vitro Diagnostic Medical Device Manufacturer

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

FDA Issues Two Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate Drug Developers

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

FDA Issues Guidance on Use of 3D Printing on Medical Devices, Accessories, Components, and Parts

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

Discontinuance and Interruptions in Manufacturing During COVID-19

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

FDA Issues Guidance on Clinical Trials During the COVID-19 Pandemic

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

FDA Releases Final Guidance: Transition of Previously Approved Drugs to Being "Deemed Licensed" Biologics

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

FDA Issues Draft Guidance on Determining Sameness of Gene Therapies

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

Court Holds the FDA Cannot Classify an Imaging Agent Medical Device as a Drug

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

A Preliminary Evaluation of the RMAT Designation's Effect on Publicly Traded Company Stock Price

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

Despite Easy Confirmation, Difficult Issues Lie Ahead for New FDA Commissioner Stephen Hahn

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

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