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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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.

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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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Pharmaceutical Technology

JANUARY 6, 2023

In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Fighting Entresto generics. 10,633,344. Free 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. 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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The FDA Law Blog

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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Pharmaceutical Technology

JANUARY 15, 2023

In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children. The EMA also expanded the label of AbbVie’s Skyrizi (risankizumab) to include its use to treat moderate-to-severe Crohn’s disease.

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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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. It is just a matter of time.”. Free Report. How is the Biopharmaceutical industry evolving?

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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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Labelling FDA Communication 52

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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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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The Checkup by Singlecare

DECEMBER 15, 2022

Cyberbullying Research Center , 2021). Ditch the Label , 2017). Ditch the Label , 2017). A survey by Ditch the Label looked into young people in the UK who reported cyberbullying and the effects on their mental health. It’s best for parents to properly monitor their children’s internet communications.”.

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Labelling Insurance Communication 52

Hospital Pharmacy Europe

FEBRUARY 22, 2024

Their training and skills enable them to interpret and communicate complex medicines-related information to patients and other health professionals. Clin Pharmacol Ther 2021 Jun;109(6):1528–37 Pirmohamed M et al. Gene 2019 Nov 15;718:144050 Clinical Pharmacogenetics Implementation Consortium. Guidelines [online] McInnes G et al.

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Pharmaceutical Technology

JUNE 1, 2023

After this, patients receiving a placebo were switched to the frexalimab arm and entered the ongoing open-label part B portion of the study. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. This represents annual growth of 4.6% from the $18.9bn recorded in 2020.

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The FDA Law Blog

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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Pharmaceutical Technology

MAY 30, 2023

The data is exploratory and the company has not yet announced any plans to expand Orsedu’s label. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving? Please check your email to download the Report.

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Labelling Communication FDA 59

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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Please check your email to download the Report.

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FDA Labelling Communication 59

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). 2021 was a year of continued innovation and change in the Biopharmaceutical industry. It plans to work with the FDA to plan new analyses and further develop a new application package.

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FDA Packaging Labelling Communication 52

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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Pharmaceutical Technology

DECEMBER 22, 2022

However, now that the implementation of Regulation (EU) 2021/2282 on health technology assessment (HTA) is a reality, a constructive discussion between the industry and regulators is needed. He believed that EUnetHTA’s conclusions will most likely influence the pricing and reimbursement decision of the drug at the national level.

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ISPE

JULY 10, 2023

In sections where we applied ChatGPT for example cases, we indicate this as such: The question or remark from us is labeled as Authors. This so-called zero-shot approach has the strong advantage that no data must be labeled for the tailoring step and that the same model can be used for many different NLP applications.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. 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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ISPE

MAY 10, 2023

Big Data Research 24 (15 May 2021): 100172. 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” You may unsubscribe from these ISPE communications at any time. González-Vélez, J. García-Gómez, et al. doi:10.1016/j.bdr.2020.100172 2020.100172 9 European Commission.

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Chemotherapy Documentation Dosage Labelling 52

ISPE

MARCH 29, 2023

Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 15, 2023

query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. 33 Fixtures and fittings with a WaterSense label, can achieve a 20% reduction in indoor water use.

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

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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 FDA Communication 59

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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Labelling FDA Vaccines Communication 40

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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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Is the software performing an action on data different from storage, archival, communication, or simple search?

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Is the software performing an action on data different from storage, archival, communication, or simple search?

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Hospital Pharmacy Europe

APRIL 14, 2025

However, issues arose due to a lack of PAAP, insufficient communication between or within services and families, failure to recognise child deterioration, and treatment delays. Learnings from the CDOPs showed that allergy symptoms were not always communicated to healthcare professionals. Why asthma still kills. Accessed March 2025].

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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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ISPE

AUGUST 30, 2022

5 (September/October 2021). The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements. 2021.09.046 2021. Published 2008. Guidance for Industry.

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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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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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