Pharmaceutical Technology

MAY 3, 2023

In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201. With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. Tenaya is also running two supplementary non-interventional studies for the drug.

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Hospital Pharmacy Europe

DECEMBER 18, 2023

There are often difficulties with adherence from multiple causes including communication difficulties, dysphagia, polypharmacy and adverse drug events. J Geriatric Oncol 2023 ; 101450 Mohamed MR et al. J Am Geriatr Soc 2023;Oct 11: doi:10.1111/jgs.18585 Lancet Healthy Longev 2022;3:e617–e627 Mohamed MR et al.

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The FDA Law Blog

JUNE 27, 2023

On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023. There are drawbacks to the current communication channels: 1.)

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ISPE

JULY 19, 2023

™ Is Gaining Momentum and Driving Innovation Trudy Patterson Wed, 07/19/2023 - 08:17 Online Exclusives July / August 2023 Pharma 4.0™ ™ Is Gaining Momentum and Driving Innovation Thomas ZIMMER, PhD 19 July 2023 The fifth Pharma 4.0™ and management communication strategy. ISPE Pharma 4.0™ Information Systems DI Pharma 4.0™

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pharmaphorum

AUGUST 11, 2021

On Axsome’s second-quarter results call, chief executive Herriot Tabuteau said that the FDA letter received on 30 July indicated that the problems with the filing “preclude discussion of labelling and post-marketing requirements,” adding that the company has been in communication with the regulator to try to learn more.

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The Checkup by Singlecare

OCTOBER 3, 2023

How to minimize hydroxyzine interactions Awareness and communication are your biggest allies in staying safe during medical treatment. Just because they are found in nature does not mean that herbs cannot harm you or interact with drugs like hydroxyzine.

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The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. New Labeling Requirements. Option to Automate the 510(k) Summary.

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ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. By Li Jie of ClinsChain

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ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

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The Checkup by Singlecare

APRIL 5, 2024

That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment. Dr. Foxman recommends that every patient review their formulary to see how Ozempic is covered and communicate directly with their insurer for clarity on the specific requirements. “It’s

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The FDA Law Blog

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling. But a Warning Letter?

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Pharmaceutical Technology

JANUARY 6, 2023

In a press release, the company said a generic launch would damage sales in FY 2023 by $300,000. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. In September, Novartis announced its plans to petition the US Supreme Court to reverse the aforementioned decision.

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Pharmaceutical Technology

JANUARY 15, 2023

In the first 2023 edition of the CMO Moves monthly series , Pharmaceutical Technology explores recent news stories on regulatory and reimbursement decisions in different countries, and the companies linked to their success and failures. FDA expands approval labels. Please check your email to download the Report.

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The Checkup by Singlecare

MARCH 7, 2024

The Adderall drug label shows no reports of adverse effects in a breastfeeding infant, but long-term effects are unknown. Boxed warning for Adderall In 2023, the FDA added a boxed warning, also called a black box warning , on ADHD drugs due to their potential for addiction and misuse. Bottom line: Is Adderall safe for females?

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The Checkup by Singlecare

JANUARY 23, 2024

Communicate these lists to every healthcare provider that cares for you. When to talk to a healthcare provider about amlodipine interactions Besides keeping and communicating lists, you should ask about interactions every time you are prescribed a new medication or are about to take an over-the-counter product.

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The Checkup by Singlecare

JANUARY 30, 2024

Hailing from the selective serotonin-reuptake inhibitor ( SSRI ) class of drugs, citalopram is often used for the treatment of major depressive disorder or off-label use treating anxiety disorder. These communication efforts can make all the difference. For all the good work that it does, citalopram also has its downsides.

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The Checkup by Singlecare

OCTOBER 27, 2023

How to minimize amoxicillin-potassium clavulanate interactions Your best bet to avoid drug-drug interactions involving amoxicillin-potassium clavulanate is to communicate well with your medical providers.

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The FDA Law Blog

OCTOBER 10, 2023

Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.

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The Checkup by Singlecare

JANUARY 18, 2024

Hence, it is important to communicate openly with your healthcare providers about all medications, vitamins, and supplements you take to ensure proper medical advice and monitoring. Eliquis and grapefruit Grapefruit and grapefruit juice interact with the effectiveness of many medicines due to binding to the enzyme CYP3A4.

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ISPE

JULY 10, 2023

ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Trudy Patterson Mon, 07/10/2023 - 15:37 Technical July / August 2023 ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Martin Heitmann, FRM Stefan MÜNCH Brandi M. The response by ChatGPT is marked as ChatGPT.

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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Pharmaceutical Technology

MARCH 20, 2023

According to GlobalData figures, the worldwide percentage of clinical trials started and completed in Africa between 9 December 2012 and 8 March 2023 was 2.2%. Rates of non-communicable diseases such as hypertension, cardiovascular disease, chronic respiratory diseases, diabetes, and cancers are also considered high throughout Africa.

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Pharmaceutical Technology

MAY 23, 2023

In its Q1 report , Centessa stated plans to present more data from part five of the open-label expansion of the Phase IIa study, subject to completion, at an undisclosed scientific meeting in 2023. The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time.

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The Checkup by Singlecare

JANUARY 9, 2024

How to minimize dicyclomine interactions Communication is key to keeping medicines safe. Sources Dicyclomine: drug information , UpToDate (2023) Bentyl label , FDA (2011) Dicyclomine hydrochloride drug label , NIH DailyMed (2020) The post Dicyclomine interactions to avoid appeared first on The Checkup.

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The Checkup by Singlecare

DECEMBER 6, 2023

Check food labels for inclusion of propylene glycol while on a course of metronidazole. Communicate directly with a healthcare professional anytime you require metronidazole so that a comprehensive review of interactions—of both medications, diet, and conditions—can occur to ensure a proper monitoring plan is put in place.

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ISPE

MAY 10, 2023

SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies Trudy Patterson Wed, 05/10/2023 - 09:25 Features May / June 2023 SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies Mariola Mier David Cerrai, Ph.D. 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.”

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ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Currently, it takes time and/or communications (e.g., Brown Megan E. McMahon Timothy J.N.

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ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Currently, it takes time and/or communications (e.g., Brown Megan E. McMahon Timothy J.N.

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ISPE

MARCH 15, 2023

Environmental Sustainability in Biopharmaceutical Facility Design Trudy Patterson Wed, 03/15/2023 - 09:13 Online Exclusives March / April 2023 Environmental Sustainability in Biopharmaceutical Facility Design William G. Table 2: Organization and labeling examples for environmental sustainability issues. Accessed 3 December 2022.

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The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. As background, 21 C.F.R.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Pharmaceutical Technology

MARCH 21, 2023

A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older.

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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 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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The Checkup by Singlecare

NOVEMBER 30, 2023

Available under the brand names Neurontin , Gralise , and Horizant , gabapentin is also commonly prescribed off-label for general nerve pain, migraines , and bipolar disorder. Off-label use is when a drug is used for a purpose other than what it is approved for. In some cases, these may be related to drug interaction.

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The Checkup by Singlecare

NOVEMBER 11, 2023

Communication is the second necessary precaution. When to talk to a healthcare provider about Imodium interactions Part of the key to good communication concerning safety in healthcare is being willing to speak up. Keep a list of prescription drugs , over-the-counter drugs, and supplements.

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Hospital Pharmacy Europe

APRIL 14, 2025

The recent National Child Mortality Database (NCMD) thematic report 6 analysed deaths over a four-year period from April 2019 to March 2023 in children with confirmed or suspected asthma as the cause of death. Learnings from the CDOPs showed that allergy symptoms were not always communicated to healthcare professionals.

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