Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 64

Labelling Communication Documentation 64

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. There are drawbacks to the current communication channels: 1.)

Documentation 59

Documentation Labelling Communication 59

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). One of them was about the appropriate use of links.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

Viseven

JULY 25, 2024

billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry. Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work. For example, Pfizer was fined $2.3

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

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. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

Documentation 75

Documentation Packaging Communication Labelling 75

pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. The mindset that accomplished this needs to be retained,” Jeremy says. About the interviewees.

Communication 130

Communication Documentation Labelling Vaccines 130

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Documentation 52

Documentation Packaging Communication Customer Service 52

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

GMPSOP

AUGUST 23, 2022

Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. process change, product recall, labelling change, adverse event/safety reporting)?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Method Validation Packaging Labelling 52

pharmacy mentor

OCTOBER 22, 2024

This technology is reforming the management of prescriptions, enhancing the accuracy of medication dispensing, streamlining communication with healthcare providers, and allowing pharmacists to devote more time to patient care. In traditional settings, communicating such critical information can take hours or even days.

Communication 52

Communication Prescription Management Medication Dispensing Payment Processing 52

Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. The agency sent out 9 alerts during the first half of the year, 4 of which were related to COVID-19, including one for the off-label use of anti-malaria medications.

Communication 61

Communication Documentation Labelling 61

GMPSOP

AUGUST 28, 2023

Raw materials must be inspected to confirm that the containers are intact, have been provided according to the paperwork, and have labels affixed on them identifying the raw material name, batch number, and expiry date. For example, materials with Hold, Quarantine, or Rejected labels must be kept in a quarantine location.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

pharmaphorum

OCTOBER 4, 2022

The FDA explains that regardless of the complexity of the software and whether or not the software is proprietary, the output or labelling should provide HCP users with adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation. Criteria for regulation.

Documentation 105

Documentation Labelling Communication 105

GMPSOP

DECEMBER 6, 2024

All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately. Additional documents included each month. Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Documentation 45

Documentation Labelling Communication 45

GMPSOP

NOVEMBER 6, 2022

Additional documents included each month. After the preparation secondary reference standards are tested for potency, labelled, dated and stored, handled and used in testing so as not prejudice quality. d) When the reference standard is first opened, an “opened date” must be written on the label of the vial.

Labelling 52

Labelling Documentation Packaging Communication 52

GMPSOP

JULY 14, 2023

Additional documents included each month. Additional documents included each month. Cleaning requirements for dedicated equipment may be less than those for common equipment, provided the company has documented either the maximum number of batches or the maximum time that can elapse before complete cleaning must be done.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

GMPSOP

MARCH 4, 2023

Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Communication Method Validation Packaging 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.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. Additional documents included each month. – Status control: implementing status labels to clearly identify workflow status such as issues, returns, rejects and reworks of components to prevent mix ups.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Quality Matters

AUGUST 3, 2023

ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g., This risk assessment effort is not a one-time event but rather a periodic, recurring process for communicating and reviewing risks,” noted USP’s Horacio Pappa, Ph.D., active ingredients, excipients, other raw materials) Packaging materials (e.g.,

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

Packaging 59

Packaging Documentation Labelling Communication 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.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

GMPSOP

MARCH 20, 2024

Additional documents included each month. Additional documents included each month. You should identify and document the instrument ID, date and time of calibration, units of measurement, the standards used, the steps taken during calibration, and environmental conditions. Additional documents included each month.

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

GMPSOP

JULY 31, 2023

These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results. Installation qualification verifies and documents that all critical aspects of equipment installation adhere to predetermined specifications and manufacturer’s recommendations.

Documentation 52

Documentation Dosage Labelling Data Entry 52

pharmaphorum

OCTOBER 27, 2022

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

Communication 98

Communication Pharmaceutical Manufacturing Packaging Documentation 98

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

FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Would any such failure to meet DAP goals be reflected in labeling?

Drug Development 59

Drug Development Communication Documentation Labelling 59

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 Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Exp Toxicol Pathol. Exp Toxicol Pathol.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling 52

Labelling Packaging Documentation Dosage 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 98

Dosage Documentation Diabetes Labelling 98

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

Documentation 71

Documentation Labelling Method Validation Communication 71

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”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Please check your email to download the Report.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97