FDA Law Blog: Biosimilars

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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Labelling Vaccines Communication 40

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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. This article summarises the most important lessons learnt during 2020 – 2021. Lessons learnt 2020-2021.

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Labelling Vaccines Communication 105

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

Considerations include transparency regarding the data used to develop the change, comprehensive testing of the change, characterizing the performance of the device before and after the change, and plans in place for ongoing monitoring of device performance and communication of any unexpected changes in performance.

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Labelling Communication 115

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. Consultancy.uk; 2021 [cited 2022Sep]. 2021 [cited 2022Sep]. References.

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Packaging Dosage Labelling Communication 98

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. J&J’s size meant that it had the resources to bring to bear against COVID-19 as the pandemic ravaged the world in 2020 and 2021, and the company soon began work on its own vaccine in partnership with the US government.

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Vaccines Biosimilars Labelling Communication 126

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]. 2021 Aug 1;37(8):435-436. Transverse view of the right kidney Figure 4. Gillon et al.,

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Labelling Communication 177

FDA Law Blog: Biosimilars

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.

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Labelling Controlled Substances Communication 52

pharmaphorum

JULY 11, 2021

The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the communications between the FDA and the company and the process that led to the approval of Aduhelm (aducanumab). — Dr. Janet Woodcock (@DrWoodcockFDA) July 9, 2021.

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Labelling Communication 52

Pulses

AUGUST 31, 2023

2021:55-77. Cross reality (XR): Challenges and opportunities across the spectrum. Innovative learning environments in STEM higher education: Opportunities, challenges, and looking forward. Onime C, Uhomoibhi J, Wang H, Santachiara M. A reclassification of markers for mixed reality environments. Campus-wide information systems.

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Medication Dispensing Medication Labelling Packaging Labelling 78

European Pharmaceutical Review

SEPTEMBER 22, 2023

Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. In 2021, she was awarded the first SEF.WomenAward for CEO of the Year by the Swiss Economic Forum. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Wang CY, et al.

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Immunization Immunity Vaccines Communication 97

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

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 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

pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We Akiko Iwasaki (@VirusesImmunity) January 1, 2021. “I Just received this email cancelling my 2nd dose of the Pfizer vaccine. pic.twitter.com/ZDtIjm1z8W.

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Vaccines Immunization Immunity Medical Schools 59

pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why. “We 8/n) [link].

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Vaccines Immunization Immunity Medical Schools 59

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 Labelling HIPAA 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

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.

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Packaging Documentation Labelling Communication 59

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

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.” Published 2021 Jul 28. Published 2021 Oct 8. thingsIlearnedthehardway).

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Health and Personal Care Stores Immunization Immunity Grocery Stores 105

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Comprehensive Transparency: AI applications should be fully disclosed, explainable, and accessible to patients and providers in layperson terms.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

PharmaShots

APRIL 3, 2023

The company is currently conducting a P-III clinical trial of JR-141 in the US, Brazil, and the EU Under the 2021 collaboration, Takeda was responsible to commercialize JR141 outside of the US incl.

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Biosimilars Diabetes Compounding Hospitals 40

Eye on FDA

MARCH 10, 2021

As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products. The subject matter was a DTC video.

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Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 72

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. Published 2021 May 10. 2021.662582.

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Dosage Labelling Communication Compounding 122

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?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

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. Published 2021 Jun 29. Published 2021 Sep 15. Published 2021 Jun 29. link] Published April 8, 2021. She was fierce, fun, dedicated, and brilliant. 2018; 7(12). Intest Res.

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Health and Personal Care Stores Immunization Immunity Dosage 98

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 Immunization Immunity Compounding 99

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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Labelling Communication 98

Pharmaceutical Technology

MAY 12, 2023

According to the FDA update, current labels for these drugs do not have up-to-date warnings about the risks of drug misuse and abuse and fail to mention that most individuals who misuse prescription stimulants source drugs from other family members or peers. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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Labelling Patient Counseling Communication 59

Pharmaceutical Technology

MARCH 6, 2023

Based on preclinical research for their impact on aging, well-known drugs like metformin and rapamycin are already being considered for off-label usage, due to their accepted safety profile and cost-effectiveness. Bellantuono worries that labeling aging as a disease indication could be “agist” and would have social implications.

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Labelling Communication Diabetes Pharmaceutical Companies 145

Pharmaceutical Technology

JUNE 7, 2023

AstraZeneca will now proceed with regulatory filings in the US and EU to convert to full label approval, with full results from the trial to be presented at a forthcoming medical meeting. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?

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Labelling Communication 105

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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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Mayo Clinic Labelling Communication 97

Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. weight reduction in obese individuals, as per its label. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. compared to a 5.1%

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Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. weight reduction in obese individuals, as per its label. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. compared to a 5.1%

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

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. Please check your email to download the Report.

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Chemotherapy Labelling Communication 52

Pharmaceutical Technology

JUNE 16, 2023

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. This latest study approval follows a previous open-label, multi-centre Phase II trial conducted in China (NCT03693547). as the secondary endpoints. ORR, 81.0% DCR (disease control rate), 4.37

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Chemotherapy Labelling Communication Pharmaceutical Companies 52