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One of the most significant challenges is keeping up with the changing regulatory requirements set by agencies such as the US FDA, EMA and International Council for Harmonisation (ICH). For solid dosage forms, including capsules, tablets, or film-coated tablets, dissolution tests are conducted. Any identified gaps have been addressed.
Today, digital-first strategies dominate, emphasizing email marketing, display ads, social media, webinars, and branded content. All CTAs should align with FDA regulations and be vetted by MLR (Medical, Legal, Regulatory) teams. How can CTAs remain compliant with FDA guidelines? Learn more.” What makes a good CTA for HCPs?
Whether thats requesting medical samples, signing up for a webinar, or downloading patient education materials , CRO helps ensure visitors dont just browsethey take action. Offer interactive tools like symptom checkers and dosage calculators. But patients often abandon pages if content is confusing or lacks trust signals.
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
A recent draft from the FDA provides valuable insight. In this exclusive webinar, Dr. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?
Despite worried hand-wringing over a potential slowdown in FDA approvals under the new administration, the agency has been giving the go-ahead to drugs at a near record-setting clip. Meanwhile, the decision-making production has come during a major upheaval inside the FDA. Please let us know if you have feedback.
A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.
For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements. This education can be delivered through various formats, such as webinars, videos, and written materials.
In addition, the dosage [of 2000 IU per day] used in the research is far below the target dose for correcting vitamin D deficiency, which is usually 50,000 IU per week,” Carvalho-Pessoa said in a news release. 1,2 “Even with a small sample of participants, it was possible to observe a significant difference in the response to chemotherapy.
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The biosimilar demonstrated comparable efficacy and safety to Stelara in a phase 3 clinical trial, supporting its FDA approval. Steqeyma provides a new dosage form and strength, enhancing treatment flexibility for young patients with chronic inflammatory conditions.
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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2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. In October 2024, CAR T therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) received FDA regenerative medicine advanced therapy designation as a first-line treatment for high-risk large B-cell lymphoma.
Selection of an appropriate OTC analgesic should take into consideration various patient factors, including the patient’s overall health status, current medical conditions, and medication profile, as well as patient preferences, which are often influenced by dosage form, required dosing intervals, and cost of OTC medication.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Image credit: Shutter2U | stock.adobe.com Biosimilars are biologic products highly similar to an FDA-approved reference product, with no clinically meaningful differences in safety, purity, or potency. Misconceptions can lead to unnecessary hesitation, increased health care spending, and reduced access to important biologic treatments.
It will be interesting to see what dosage form these data prompt the future development of. It also introduces a question on how to optimize the PK/pharmacodynamic profile for protein degraders, such as cereblon E3 ligase modulatory drugs and proteolysis-targeting chimeras, which are a burgeoning area of therapeutic development.”
Both agents received FDA approval for the treatment of patients with RRMM who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The investigators assessed a total of 90 patients who received talquetamab at a dosage of 0.8 mg/kg every 2 weeks.
SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The phase 3 ECHO trial showed significant progression-free survival improvement with acalabrutinib, supporting its approval as a new standard of care for untreated MCL.
FDA approval of LIMITX for broader use could significantly impact opioid misuse prevention and save lives. Or, as FDA officials like to call it, “multiple tablet ingestion”—I guess it sounds better to them. trillion economic impact in 2020. SHOW MORE A novel solution can strategically control the release of the drug in vivo.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
This international study is ongoing despite the recent FDA decision to reject MDMA-assisted therapy for PTSD, and it has the potential to add another treatment paradigm for patients with cancer. Potential Roles of the Oncology Pharmacist My friend died of his metastatic cancer in early 2025.
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