pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. Novartis took ownership of the drug in 2015. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Hospitals 111

Hospitals Documentation 111

pharmaphorum

MARCH 5, 2021

Teva’s Copaxone patent expired in Europe in 2015 and the Commission said it will investigate whether the company broke antitrust rules by defending the drug’s market position after the expiry. Now the European Commission has opened an investigation to see whether Teva acted illegally by blocking competition for Copaxone in the EU.

Documentation 98

Documentation Communication Hospitals 98

ISPE

SEPTEMBER 15, 2022

In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments.

Documentation 97

Documentation FDA 97

ISPE

AUGUST 17, 2023

The digitization of paper forms and documents has been a crucial first step in this process, but now we are seeing a shift towards the electronic generation and management of data. For one, electronic data can be stored and accessed more easily than physical documents.

Documentation 98

Documentation 98

pharmaphorum

MARCH 23, 2021

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Tanezumab is now the most developed of the two remaining drugs in development in the NGF class, in pain caused by osteoarthritis.

FDA 59

FDA Documentation 59

Hospital Pharmacy Europe

MAY 17, 2023

But in its consultation documents, the GPhC said ‘now is not the right time to adopt a multi-year approach’, putting this down to a considerable change in the economic conditions since the proposal was originally made. What about international applicants?

Documentation 97

Documentation Hospitals 97

pharmaphorum

DECEMBER 29, 2022

The complaint claims that Par agreed not to launch its generic, in return for Novartis not launching a patent infringement suit and agreeing not to launch its own authorised generic of the drug until 30 March, 2015, giving Par a valuable six months to sell its generic unopposed in the market.

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

pharmaphorum

FEBRUARY 26, 2021

From 2015 to 2017, when the cost of the drug was falling, the three suppliers exchanged information about prices, the volumes they were supplying, and Alissa’s plans to enter the market,” said the CMA.

Documentation 52

Documentation 52

ISPE

SEPTEMBER 8, 2023

We have 19 committees, councils, and working groups that are doing incredible work bringing visibility to the industry’s regulatory challenges and developing solutions that are delivered through ISPE content outlets: webinars, PE magazine articles, iSpeak blog posts, training materials, conference sessions, and ISPE Guidance Documents.

Documentation 91

Documentation 91

The FDA Law Blog

FEBRUARY 21, 2024

Subpart A – General Provisions Subpart A – General Provisions, incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015 (new § 820.7), and requirements for a quality management system (new § 820.10). The new § 820.10 Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

FDA 59

FDA Labelling Packaging Documentation 59

ISPE

JULY 7, 2023

He is currently co-leading the team working on an ISPE guidance document addressing Pharma 4.0™. We developed recipe management and manufacturing software which controlled and documented these processes.” ™ in 2015 as a “plug and produce” concept to bridge the automation concepts found in Industry 4.0

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JULY 27, 2022

These values have seen a year-on-year decline since 2016 for exports and 2015 for imports, in contrast with a general upward trend seen in most comparator countries, said the ABPI. In 2020, exports were valued at $25.9bn, placing the UK ninth out of 20 countries, and imports at $26.8bn, meaning a ranking of tenth out of 20.

Documentation 98

Documentation FDA 98

The Pharmacist Blog

MARCH 21, 2015

It is March and already my motivation to complete my goals for the year of 2015 has been waning. Even in this blog I document my goals and publicize them to hold myself accountable. It is strange how I felt so much energy and motivation to be productive in January. My energy overall seems to be declining each day.

Documentation 52

Documentation 52

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance?

Documentation 98

Documentation FDA Labelling Communication 98

pharmaphorum

OCTOBER 29, 2020

Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA). For PRIMA, the agency quotes Peter Wheatley-Price, market access and pricing director at Takeda UK, who said : “The Takeda team highly regarded the quality of the PRIMA reports and model review documentation.

Documentation 101

Documentation 101

pharmaphorum

OCTOBER 30, 2022

The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

FDA 52

FDA Documentation Labelling Immunization 52

Druggist

FEBRUARY 17, 2021

The mechanism action of local anaesthetic creams is well defined, and their effectiveness well documented. 2015 Jul;135(7):1790-1800. Epub 2015 Feb 23. Lanacaine and other skin numbing creams cause a local loss of pain sensation. Who can use Lanacane cream? Lanacane is licensed for adults and children from 12 years of age.

Compounding 98

Compounding Documentation Labelling 98

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation FDA Hospitals Dosage 97

Board Vitals - Pharmacist

FEBRUARY 5, 2020

between 2012 and 2015. The benefits offered by advanced level practitioners to practice is well documented as well. The study said, “Most of these specialists were advanced practitioners, physician assistants and nurse practitioners, delivering post-acute care.” or lower.”

Nursing Homes 52

Nursing Homes Hospitals Documentation Patient Care 52

pharmaphorum

JANUARY 4, 2022

Everything started to unravel however when a Wall Street Journal investigation in 2015 discovered that most of the tests Theranos claimed to perform on its analyser were actually being performed by standard blood-testing machines.

Documentation 52

Documentation Communication FDA 52

Hospital Pharmacy Europe

JUNE 8, 2023

In a 2015 systematic review of registered and published outcomes in randomised trials, researchers found that discrepancies between registered and published outcomes of clinical trials were common. Later work simply re-affirmed this finding.

Documentation 52

Documentation Communication Patient Care Hospitals 52

The Checkup by Singlecare

FEBRUARY 28, 2024

In 2015, Pennsylvania became one of 41 states to adopt the Affordable Care Act (ACA) Medicaid expansion. Eligibility for Pennsylvania Medicaid Since adopting the ACA Medicaid expansion in 2015, Pennsylvania has implemented targeted enrollment strategies to help eligible Pennsylvanians gain coverage. million Pennsylvania residents.

Packaging 52

Packaging Documentation Hospitals Insurance 52

The FDA Law Blog

FEBRUARY 29, 2024

According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

FDA 59

FDA Documentation 59

Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 2015: PhRMA won a lawsuit against HRSA regarding orphan drugs. 340B providers expressed significant concern.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

DiversifyRx

JULY 11, 2024

Most of the existing requirements have been in place since 2015 and require Pharmacies to have SOPs, Training, and data storage (or agreements with their ATPs in place) to maintain the required transaction data. The four requirements below are handled in various ways. Identifiers All products received must contain a product identifier.

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

Hospital Pharmacy Europe

APRIL 12, 2024

The service was piloted between October 2015 and December 2016 among 270 patients. This left him with extensive deconditioning and multiple morbidities – all of which he has documented in a Journal of Cardiac Failure editorial. After identifying a barrier, Dr Khatib adds, he can work with the patient to overcome them.

Hospitals 83

Hospitals Documentation Patient Care 83

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.

Documentation 52

Documentation FDA Dosage Pharmaceutical Companies 52

Hospital Pharmacy Europe

JULY 3, 2024

Current state of play in ED pharmacy practice Fast-forward to 2015 and, due to shortages of physicians and nurse practitioners, NHS England commissioned the Pharmacists in Emergency Departments (PIED) study. Recognition is about developing concerns or suspicions as to whether a patient has been maltreated. Int J Clin Pharm 2019;41:434–44.

Hospitals 52

Hospitals Communication Patient Care Packaging 52

Pharmaceutical Technology

MAY 23, 2023

In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 52

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

FDA 52

FDA Labelling Packaging Documentation 52

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. April 2015. to Industry 4.0 2 3 a b Hankel, M.,

Packaging 52

Packaging Documentation Communication Data Entry 52

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]. Hum Psychopharmacol, 2015. 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

ISPE

SEPTEMBER 11, 2023

Regulatory Background and Cleanroom Air Velocity In 2015, the authors of the Concept Paper on Revision of Annex 1 decided to harmonize the regulatory framework globally, including established methodologies such as those from the International Organization for Standardization (ISO). Published 2 February 2015. m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 52

Druggist

SEPTEMBER 7, 2020

However, it has been documented that when used regularly, tolerance develops rapidly (Vande Griend, Anderson, 2003), within a few days of starting the treatment. Published 2015 Jan 5. Published 2014 Nov 7. doi:10.1186/1475-2891-13-106 Available at: [link] Accessed on 05/09/2020 Daneman R, Prat A. The blood-brain barrier.

Documentation 94

Documentation 94

ISPE

MARCH 7, 2023

October 2015. 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] 2 United Nations. Climate Change.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

IDStewardship

APRIL 13, 2023

In 2015 a National Action Plan for Combating Antibiotic Resistant Bacteria was released, known as CARB. The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

Hospitals 246

Hospitals Documentation Communication Patient Care 246

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

Documentation 52

Documentation FDA Communication Packaging 52