Pharmacovigilance and Medical Writing Consultant

FDA finalizes guidance on patient-focused drug development

From the desk of FDA- 28-Feb-2022 The US Food and Drug Administration (FDA) on Friday finalized guidance that describe in a stepwise manner how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers under the patient-focused drug development (PFDD) initiative. The…

Effective Tips for Virtual Team Management

In the 1970s, the OPEC oil crisis and rising fuel costs led Jack Nilles (sometimes called “The Father of Teleworking”) to look for ways to reduce the cost of driving to work. He conducted the first formal tests of telecommuting and coined the term “telecommuting” in his book The Telecommunications-Transportation Tradeoff. Telecommuting grew rapidly from there resulting in virtual teams of…

MHRA publishes guidance on the use of real-world data in clinical trials

From the desk of MHRA- 16 December 2021 The UK Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on using real-world data (RWD) to support regulatory decision-making in clinical studies. The MHRA believes that the guidance will help patients receive medicines more quickly. The guideline defines RWD as data relating to patient health status or delivery of health care…

Pharmaceutical stakeholders request clarity on ICH guideline

From the desk of FDA- 17 December 2021 Pharmaceutical stakeholders are requesting for more clarity on the International Council for Harmonization’s (ICH) Q13 guideline on continuous manufacturing. The ICH Q13 guideline, released on 27 July 2021, is titled continuous manufacturing of drug substances and drug products whose scope includes chemical entities and therapeutic proteins. The guideline…

EMA extends scope of GMO trial guidelines

From the desk of EMA- 11-Nov-2021 The European Commission (EC) has extended the scope of its guideline on the assessment of the genetically modified organism (GMO)-related aspects of clinical trials that study human cells. The guideline has been revised to include human cells that are genetically modified without viral vectors and genome edited cells.The guideline discusses the environmental…

Finland Passes New Clinical Trial Regulations

From the desk of FMEA- October 22, 2021 A new law on clinical trials was passed in Finland to align it with upcoming European Union (EU) regulations. Most of the changes will become effective in early next year. The regulations cover topics that include, but are not limited to trials involving vulnerable subjects, fees for sponsors, payments made to subjects, and supervision of clinical trials.…

ICH guideline adds permissible daily limits for seven new mutagenic impurities

From the desk of ICH- October 06, 2021 The International Council for Harmonization (ICH) has added new permitted daily exposure (PDE) limits for seven DNA-reactive substances in the M7 guideline.  The guideline originally contained 14 mutagenic impurities and the addition makes it a total of 21 impurities for which PDE limits are defined. Also, the rationale for adding these are explained in…

From the desk of EMA- July 30, 2021 The European Medicines Agency (EMA) has updated their veterinary medicinal product guidelines to align the definitions and terminology with the new regulatory framework covering the sector. EMA has stated that the revision consists of administrative changes to align the guideline with the Veterinary Medicines Regulation that is set to take effect early next…

You have applied for the job and landed an interview. Congratulations. It is in your hands now to get hired. Read on for six tips to nail the interview. 1.       Analyze yourself Jobs are a lot like us, as in they come with their special characteristics. The first step in preparation in to analyze your strengths, weaknesses and skills and check if they align with the job requirements.…

MHRA and Health Canada have jointly published guidance that calls for clinical trial sponsors to be more transparent about how they review, evaluate and interpret data submitted in periodic safety reports. The guidance states the detailed safety assessments performed by sponsors are absent from Development Safety Update Reports (DSURs). MHRA and Health Canada want sponsors to use the…

From the desk of TGA- June 22, 2021 TGA has revised its guidance on 3D-printed devices to feature changes that reflect the new regulatory framework and updates to the legislation. This is the third version of the guidance. The new guidance starts with a history of the regulation of personalized medical devices in Australia, before going on to explain the definitions established by the new rules.…

From the desk of FDA- May 14, 2021  Electronic devices such as cell phones and smart watches that contain high field strength magnets may cause implanted medical devices such as pacemakers and cardiac defibrillators to switch to  “magnet mode”, according to the US Food and Drug Administration. Many devices have an inbuilt magnet mode that ensure safety during CT and MRI scans which suspend…

From the desk of MDA- April 13, 2020 Malaysia’s Medical Device Authority (MDA) has updated its guidance on advertising medical devices, separating the section on applying for approval of a medical device advertisement into a different document.  Under the revised rules, companies need to obtain approval for press releases about the launches of medical devices.  The guidelines state that adverts…

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From the desk of PMDA- March 16, 2021 The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has released guidance in English language on the use of physiologically based pharmacokinetic (PBPK) modeling. PMDA created the guidance in response to a rise in the use of PBPK models to investigate drug interactions, predict pharmacokinetics in children, and to determine the optimum dose and…

From the desk of CDSCO- 01 March 2021 India’s Central Drugs Standard Control Organization (CDSCO) is switching to online serious adverse event (SAE) report filing via the Sugam online portal and is expected to stop accepting physical copies from 14 March. However, companies can continue to submit physical follow-ups for events that are already in the system. CDSCO has created manual and video…

From the desk of FDA- February 19. 2021 The US Food and Drug Administration (FDA) has issued a new safety communication stating that oximeters may yield falsely elevated readings in individuals with dark skin pigmentation, with the potential of masking dangerously low blood oxygen levels.  This becomes important in the context of the COVID-19 pandemic, which has caused an increase in the use of…