pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

FDA 90

FDA Chemotherapy Documentation 90

European Pharmaceutical Review

SEPTEMBER 22, 2022

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. 2011 May; 46(3): 399–424. Patel et al. Multivariate Behav Res. doi: 1080/00273171.2011.568786. Available at: [link].

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

Omnicell

JANUARY 10, 2023

2011: The Government Accountability Office (GAO) published a study entitled: "Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement." Also, in 2011, the U.S. However, lawmakers decided that it was not needed anymore since HRSA was expanding the program on its own.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

pharmaphorum

JANUARY 12, 2023

For example, there were 12 HCV infections associated with an emergency department nurse at a hospital in Washington in 2018, and 25 gram-negative bacteremia infections in 2011 that emerged in Minnesota.

Hospitals 105

Hospitals Documentation 105

pharmaphorum

NOVEMBER 27, 2020

The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 In a statement the EU said the scheme prevented generic competition for Provigil, which is used to treat narcolepsy, after its main patents expired. billion and involved a complex series of transactions instead of an up-front payment.

Packaging 52

Packaging Documentation 52

The Checkup by Singlecare

FEBRUARY 15, 2024

However, simply having a qualifying disability typically isn’t sufficient; the person also needs documentation from a medical professional that indicates that the service animal could improve or support his or her condition. Since March 15, 2011, only dogs a re officially recognized as service animals under titles II and III of the ADA.

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

FDA 59

FDA Documentation Labelling 59

PQA

MARCH 28, 2025

Milestones include endorsement of the Completion Rate for Comprehensive Medication Review performance measure in 2011 and development of the foundational Medication Therapy Problem Categories Framework in 2017. The evolution of PQAs continued involvement in medication therapy management (MTM) spans over a decade.

Documentation 40

Documentation Patient Care 40

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

Documentation 97

Documentation Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

DECEMBER 29, 2022

The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

The Checkup by Singlecare

JANUARY 3, 2024

The benefits are well-known—and well-documented in the popular press—but what about the potential downsides? That’s how it works its magic for blood glucose and weight loss. Strange side effects, such as Ozempic face and Ozempic butt have also made the news. Are tiredness and fatigue one of them?

Documentation 105

Documentation Compounding Dosage Labelling 105

pharmaphorum

FEBRUARY 26, 2021

That period was preceded by several years in which the price of nortriptyline had been rising dramatically, with NHS spending on the drug escalating from just over £6 million in 2011 to £38 million in 2015.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Druggist

APRIL 29, 2021

2011): Apixaban was superior ( better ) to warfarin in preventing stroke/ clots formation in patients with atrial fibrillation. More details can be found in a document called Guidance for the safe switching of warfarin to direct oral anticoagulants (DOACs) for patients with non-valvular AF and venous thromboembolism (DVT / PE).

Chemotherapy 98

Chemotherapy Documentation Compounding Dosage 98

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2011, following referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a small development stage pharmaceutical company located in the United Kingdom to assist them with pre-IND activities for a new chemical entity for the treatment of asthma. Authored the client’s Pre-IND Briefing Document.

Documentation 40

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 40

The Checkup by Singlecare

DECEMBER 1, 2023

In 2011, the agency reported that it could not establish a relationship between color additives and hyperactivity in children in the general population. The FDA has denied any link between the two for years.

Labelling 52

Labelling FDA Documentation 52

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. This research paved the way for the first successful treatment of a patient with acute lymphoblastic leukaemia in 2011. 1844 – First reported case of multiple myeloma. 2012 – The 100,000 Genomics Project begins.

Chemotherapy 98

Chemotherapy Immunization FDA Documentation 98

The FDA Law Blog

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect. GSK filed a supplemental brief in response to the Government’s brief.

Labelling 72

Labelling FDA Documentation Communication 72

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Directive 2011/62/EU of the European Parliament and of the Council.” Published 2011.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

ISPE

JULY 6, 2023

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done. Published December 2011.

Documentation 52

Documentation FDA Dosage Pharmaceutical Companies 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). Published January 2011. Consistent 1 US Food and Drug Administration Center for Drug Evaluation and Research.

Documentation 52

Documentation Labelling FDA 52

ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published December 2011. The assessment may also identify perception concerns. Biological (Viral and Microbial) Risk Progression. 1 US Pharmacopeial Convention.

Vaccines 97

Vaccines Compounding Documentation FDA 97

pharmaphorum

FEBRUARY 2, 2021

In 2011, government officials in Germany introduced legislation called the Arzneimittelmarkt-Neuordnungsgesetz (Act on the Reform of the Market for Medical Products, or AMNOG), which allows payers to assess products in accordance with evidence-based methods and weigh-up clinical benefit against budget impact.

Documentation 65

Documentation 65

The Spirit Pharmacist

FEBRUARY 21, 2023

There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23]. J Psychoactive Drugs, 2011. Nevertheless, several case reports of ophthalmic or limb abnormalities born to mothers who used LSD exist in medical literature [19-22].

Documentation 98

Documentation Compounding Immunization FDA 98

Hospital Pharmacy Europe

MAY 22, 2024

The UK Health Security Agency’s ‘Start smart then focus’ AMS toolkit – first published in 2011 and most recently updated in September 2023 – makes evidence-based recommendations on effective AMS practices in hospitals, including appropriate management of penicillin allergy labels.

Patient Care 52

Patient Care Labelling Hospitals Adverse Reactions 52

ISPE

JANUARY 11, 2023

5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package. January 2011.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

JULY 6, 2023

NASA Risk Management Handbook NASA/SP-2011-3422, Version 1.0. NASA Headquarters, 2011. This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities. Final Rule.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Breast milk and in-utero transmission have also been documented as a means for exposure and concern. [13]. 2011 Jan;119(1):A11. Published May 2011. Published May 2011. While some flame retardants have been banned in the U.S. Endocr Connect. 2018;7(4):R160-R186. [2] 2] Birnbaum LS, Bergman A. Environ Health Perspect.

Health and Personal Care Stores 80

Health and Personal Care Stores Labelling Immunization Compounding 80

The Checkup by Singlecare

JANUARY 18, 2024

Because numerous possible reasons could be linked to postprandial sleepiness, keeping a food journal to document these important clues on how your food affects you could be helpful.

Medical Schools 52

Medical Schools Mayo Clinic Labelling Documentation 52

ISPE

SEPTEMBER 11, 2023

Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. January 2011. en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf 66 a b DitaExchange. 22 March 2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

The Thyroid Pharmacist

MARCH 31, 2023

There are many well-documented side effects of antidepressants and benzodiazepines, ranging from the rare but serious – suicidal ideation/action, homicidal ideation/action, and even death – to the very common – brain fog , weight gain , sexual dysfunction , and feeling disconnected from reality Magnes Res. 2016;29(3):120-125. doi:10.1684/mrh.2016.0411

Immunization 105

Immunization Documentation Dosage 105

The Thyroid Pharmacist

JULY 14, 2023

This group also performed a randomized, larger placebo-controlled trial of 43 patients in 2011. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography. The remainder also saw an improvement toward normalization, reaching near-normal values. 2010;20(10):1187-1190.

Dosage 98

Dosage FDA Immunization Documentation 98

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. link] 16 International Society for Pharmaceutical Engineering.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. Published September 12, 2011. As you add your symptoms to a health history timeline, reflect on what season it was when your allergy or thyroid symptoms worsened. Accessed October 30, 2020. Paul Pestano. Environmental Working Group.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. 2011 Consecutive case series (n=12) Patients included if toxicology service was present to participate in management. Greene et al., units/kg/hr) Euglycemia was maintained using 5-10% dextrose infusions. Holger et al.,

Packaging 52

Packaging Documentation 52

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

FDA 59

FDA Documentation Labelling 59