FDA Law Blog: Biosimilars

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD). Loose Ends IDEs.

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pharmaphorum

MARCH 15, 2022

Towards the conclusion of 2021 many societies announced another shift in format; 2022 conferences would be hybrid, or increasingly and more realistically described as ‘physical with virtual participation options,’ or similar. Part 2 will assess possible scenarios for 2022 and beyond. The ‘hybrid’ label is confusing.

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Labelling Vaccines Communication 102

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.

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Documentation Labelling Communication 95

European Pharmaceutical Review

OCTOBER 5, 2022

And beyond the physical limitations, those instigating industry-wide change also face pushback in the boardroom, with a recent study citing poor communication between stakeholders and rigid practices among the key barriers to more circular product packaging. 2022 [cited 2022Sep]. Available from: [link]. Sustainability.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Clearly, OPDP thinks differently.

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Labelling Controlled Substances Communication 52

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Cysts will have a more spherical shape and will not “communicate” with one another [5]. Epub 2022 Sep 26. Transverse view of the right kidney Figure 4. Pediatr Nephrol.

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FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

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Documentation Packaging Communication Labelling 75

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Compounding Sterile Compounds Packaging Labelling 52

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. 2022 Alzheimer’s Association International Conference. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Brain Communications.2022;4(1). Wang CY, et al.

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Immunization Immunity Vaccines Communication 97

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

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Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

RX Note

MARCH 28, 2023

To illustrate, every now and then, I may encounter an off-label indication of medication that I do not know of. It is a cognitive bias that occurs when an individual, communicating with other individuals, unknowingly assumes that the others have the background to understand. Nevertheless, I still miss my free lunch, and free pens much.

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Hospitals Labelling Communication Pharmaceutical Companies 52

The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” 2022 Jul 04;12(7):]. Accessed October 4, 2022. Accessed October 7, 2022.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. 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.”

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Putting Patients First Blog

JULY 10, 2023

Communication with the FDA We appreciate that the FDA has emphasized the need for sponsors and patients to interact with the Agency early and often when utilizing these guidances. This clear communication will help achieve a smooth transition and effective application of the four guidances. Sincerely, Randall L.

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Putting Patients First Blog

DECEMBER 5, 2024

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 17 In addition to its role in pre-market decisions, PPI can be valuable in post-market activities, including the formulation and communication of recall notices. Viera, Nancy D.

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Labelling Communication Mayo Clinic 40

epicur

JANUARY 4, 2023

The product is what it says it is on the label, it’s 100% manufactured and we’re giving them a product that they can use for office administration and dispensing so they can start patient care immediately. We wrapped up 2022 at Fetch San Diego in December last year. It’s about reachability. Thanks, Branson!

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Compounding Compounding Pharmacies Hospitals Customer Service 52

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. Updated January 2022. References.

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RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Human Touch - Why Artificial Intelligence cannot replace us still? Theory in Practice - Life is not ideal but a struggle Life - Why?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

PharmaShots

APRIL 3, 2023

at current exchange rates In Oct 2022, the acquisition was initiated and the transaction is expected to be adjusted per share by $0.07 greater China region & certain other countries already out-licensed by SCYNEXIS to third parties Related Post: PharmaShots' Key Highlights of Fourth Quarter 2022 events/100 patient-yrs.)

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Biosimilars Diabetes Compounding Hospitals 40

The Thyroid Pharmacist

OCTOBER 6, 2023

Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. One participant in the 2022 beta group stated: “Your suggestions have been the only things that seem to work for me. Accessed December 21, 2022. [18] link] Accessed December 21, 2022. [42]

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The Thyroid Pharmacist

OCTOBER 27, 2023

These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Precautions Do not take more than the recommended dose on the label. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.

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Health and Personal Care Stores Immunity Immunization Compounding 98

FDA Law Blog: Biosimilars

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § Would any such failure to meet DAP goals be reflected in labeling?

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Drug Development Communication Documentation Labelling 59

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

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The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Accessed Dec 7, 2022. Published 2022 May 24. Published 2022 Feb 27. doi:10.1155/2022/1348795 [50] Zhuang W, Yue L, Dang X, et al. Evid Based Complement Alternat Med.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. To date, vaginally-applied DHEA is still only available through prescription, either as Intrarosa® or an off-label customized prescription. Accessed Dec 20, 2022.

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Dosage Documentation Diabetes Labelling 98

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. billion in 2022 alone to expand capacity. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. compared to a 5.1%

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Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. billion in 2022 alone to expand capacity. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. compared to a 5.1%

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Insurance Coverage and Processing Diabetes Labelling Communication 98

Pharmaceutical Technology

JANUARY 6, 2023

Throughout 2022, Novartis was at the opposing ends of legal cases. However, in 2022, the Greek health ministry promised renewed legal action surrounding the same criminal offences, wanting a new sum of €214 million (US$225 million) from Novartis. Fighting Entresto generics. Please check your email to download the Report.

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Pharmaceutical Technology

MAY 3, 2023

With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. In April 2022, Bristol Myers Squibb’s Camzyos (mavacamten) became the first FDA-approved cardiac myosin inhibitor to treat obstructive HCM. TN-201 is one of four AAV-based gene therapies in Tenaya’s pipeline.

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Mayo Clinic Labelling Communication 97

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Coherus Biosciences’ Cimerli, an interchangeable biosimilar for the ophthalmological treatment Lucentis made by Genentech, was launched in October 2022.

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Biosimilars Labelling Communication Hospitals 104

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. billion in Spikevax sales in 2022, and Comirnaty generating $37 million for Pfizer in 2022. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Vaccines Immunity Immunization Medical Schools 59

Pharmaceutical Technology

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. It showed promising event-free survival (EFS) of 62.4%

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Chemotherapy Labelling Communication 52

Pharmaceutical Technology

JANUARY 5, 2023

The pharmaceutical industry has long been labelled as a recession-proof—stable demand for medicines and new treatment options acts as a protective barrier. The outlook for global growth continues to deteriorate as inflation continues to significantly exceed the target of 2% in most developed markets.

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Drug Pricing Vaccines Labelling Communication 69

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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Labelling Communication Drug Development 59

Pharmaceutical Technology

MAY 24, 2023

This new plan builds on President Biden’s Executive Order on Lowering Drug Costs for Americans signed in October 2022. This includes giving CMS the power to suspend the National Drug Rebate Agreement of a labeller for less than 30 days in case of late reporting of required drug and price information.

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Drug Pricing Vaccines Labelling Communication 52

Pharmaceutical Technology

JUNE 20, 2023

Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). Earlier this year, F2G received Bionow’s 2022 Investment Deal of the Year Award for its collaboration with Shionogi to develop antifungals. Despite this, it is yet to receive approval from any regulatory body.

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Packaging Labelling Communication 52