The FDA Law Blog

FEBRUARY 27, 2023

Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. The only schedule III-V narcotic drug that is currently approved by the FDA for OUD treatment is buprenorphine.

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Pharma Marketing Network

FEBRUARY 19, 2025

Challenges in Pharma Email Marketing Pharma brands face unique barriers that other industries dont , such as: Strict compliance regulations (FDA, GDPR, HIPAA) that limit messaging. FDA and Fair Balance Messaging All promotional emails must include fair balance messaging benefits and risks must be presented equally. Ideal: 2-5% CTR ).

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The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. For instance, FDA highlights risks associated with everyday activities (e.g.,

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Pharma Marketing Network

MARCH 18, 2025

Organizations like the FDA (U.S.), Being aware of pharmaceutical advertising laws, fair balance requirements, and off-label promotion restrictions will prevent costly compliance mistakes. Combining HCP webinars, digital advertising, and interactive medical content enhances outreach effectiveness.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. The DSCSA Adventure continues.

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ISPE

JULY 19, 2023

In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed. and management communication strategy. ™ hackathons were established, and the ISPE Factory of the Year (FOYA) award category was created.

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Pharmacy Times

JUNE 11, 2025

The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.

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Pharmacy Times

JUNE 23, 2025

The FDA's decision represents progress in treating EGFR-mutated NSCLC beyond initial therapy lines. SHOW MORE Datopotamab deruxtecan gains FDA approval, offering new hope for adults with advanced EGFR-mutated non-small cell lung cancer after prior therapies.

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Pharmacy Times

JUNE 11, 2025

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. Coverage of this story is ongoing. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets.

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Pharmacy Times

JUNE 23, 2025

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

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Pharmacy Times

JUNE 16, 2025

Nemolizumab targets IL-31 receptor alpha, inhibiting itch and inflammation, and is FDA-approved for use with topical therapies in patients 12 and older. Nemolizumab also received FDA approval in August 2024 as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.

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Pharmacy Times

JUNE 12, 2025

Mitomycin intravesical solution (Zusduri, UroGen Pharma) was approved by the FDA for treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

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Pharmacy Times

JUNE 23, 2025

1 Image credit: Cynthia | stock.adobe.com The discussion featured Vivian Fonseca, MD, of the Tulane University School of Medicine, who presented an overview of tirzepatide based on the FDA-approved label and clinical guidelines. He was joined by Laura, a patient who began tirzepatide treatment shortly after being diagnosed with T2D.

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Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

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Pharmacy Times

JUNE 20, 2025

In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Whereas SPF 15 blocks approximately 93% of UV-B rays, SPF 30 and SPF 50 increase coverage slightly (97% and 98%, respectively).

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Pharmacy Times

JUNE 9, 2025

Dalton shared her surprise about how variability in manufacturing affects the patient experience, given that some products created using the patient’s cells may not always be usable or up to FDA standards. 2 For Dyke’s team, balancing research and commercial pathways have created gray areas.

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Pharmacy Times

JUNE 9, 2025

months versus 2.1 The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. It is the first PROTAC to be evaluated in a phase 3 clinical trial, according to the investigators.

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Pharmacy Times

JUNE 20, 2025

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Oncology pharmacy practice changes at a rapid pace. Fifteen years ago, pharmacists could learn oncology on the job.

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Pharmacy Times

JUNE 12, 2025

Pembrolizumab (Keytruda; Merck Sharp & Dohme LLC) has been approved by the FDA for the treatment of adult patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. This marks the first FDA approval for a perioperative treatment approach in locally advanced HNSCC.

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Pharmacy Times

JUNE 15, 2025

In the randomized, open-label, multicenter phase 3 NATALEE clinical trial (NCT05306340), ribociclib (Kisqali; Novartis) plus endocrine therapy, a nonsteroidal aromatase inhibitor (NSAI), significantly improved invasive disease-free survival among individuals with HR-positive (HR+) and HER2-negative (HER2-) early breast cancer.

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Pharmacy Times

JUNE 9, 2025

3 neoCARHP was a multicenter, open-label, randomized, noninferiority phase 3 trial (NCT04858529) that compared the efficacy and safety of TCbHP with THP in the neoadjuvant setting. If caught early, the cancer can often be treated and cured, according to Cleveland Clinic. Gao HF, Li W, Wu Z, et al. J Clin Oncol. doi:10.1200/JCO.2025.43.17_suppl.LBA500

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Pharmacy Times

JUNE 9, 2025

These conclusions were presented as part of an abstract from the open-label, phase 3 CheckMate 816 trial (NCT02998528) at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, and subsequently published in the Journal of Clinical Oncology.

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The FDA Law Blog

JANUARY 2, 2025

By Ritte van Laack As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim healthy. FDA received more than 400 comments, resulting in a final rule published on December 27, 2024, covering more than 100 pages. The final rule maintains the concept of the proposed rule.

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Pharmacy Times

JUNE 5, 2025

Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork. Image Credit: © Medi-Dose, Inc.

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The FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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The FDA Law Blog

FEBRUARY 20, 2025

Despite this impending massive change in regulatory scope, the President and his Department of Government Efficiency (DOGE) fired hundreds of FDA employees this past weekend. If this happens, laboratories will not be able to anticipate what data FDA wants. The materials from this webinar are still available on FDAs website ( here ).

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Pharmacy Times

JUNE 16, 2025

1 As part of another action designed to reduce drug costs, Newsom also announced the expansion of CalRx, the state’s initiative to produce generic drugs under the state’s own label, giving CalRx the authority to purchase brand-name drugs. Furthermore, DMHC would have clear authority to enforce rules and penalize violations.

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The FDA Law Blog

MAY 26, 2025

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one.

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