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Pink Sheet Pharma Regulatory and Policy Insights

WEBGlobal Pharma Guidance Tracker – March 2024. By Vibha Sharma. Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance …

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EMA Expands Early Engagement With Patients & Health …

WEBOn the back of a successful pilot of early consultations with patients, the European Medicines Agency is extending the initiative so that patient and health care …

Category:  Medicine Go Health

Time To Tip the Scales

WEBHumira Biosimilars And The Limitations Of Competition In US Health Care Add a personalized message to your email. Cancel. Send. Please Note: Only individuals …

Category:  Health Go Health

Pink Sheet Meet the Team :: Pink Sheet

WEBBelow is our global editorial team for all six of our pharma, medtech and consumer health and wellness publications. Content Leadership. Karen Coleman. Executive Director, …

Category:  Health Go Health

GUIDELINES FOR MARKET SURVEILLANCE OF MEDICINES

WEB3.1. SAHPRA is charged with the responsibility of regulating medicines from clinical trial phase to post-marketing surveillance phase. 3.2. Medicines include both human and …

Category:  Medicine Go Health

From COVID Cliff To GLP-1 Ramp: Novo Takes Catalent Plants For …

WEBSubject: From COVID Cliff To GLP-1 Ramp: Novo Takes Catalent Plants For Next Public Health Crisis Add a personalized message to your email. Cancel. Send. Please Note: …

Category:  Health Go Health

Data Manipulation Cited in Leiner Warning Letter :: Pink Sheet

WEBFDA's Atlanta District focused on data manipulation and inadequate testing procedures in an Aug. 28 warning letter to Leiner Health Products, Carson, Calif., based …

Category:  Health Go Health

Digital Health Technologies: Use In Clinical Studies Comes With

WEBSubject: Digital Health Technologies: Use In Clinical Studies Comes With Practical Challenges Add a personalized message to your email. Cancel. Send. Please Note: …

Category:  Health Go Health

Japan’s New Infertility Coverage To Drive The Market

WEBJapan's national health insurance scheme will reimburse infertility treatments from April 2022, in a bid to make the treatments more accessible to patients by …

Category:  Health Go Health

‘A Maze Of Rules’: EFPIA On EU’s Proposed Health Data Sharing Law

WEBEFPIA was among 35 stakeholders to speak out against the opt-out model last year, a stance on which it remains firm, Tyszkiewicz noted. (Also see "EU Health …

Category:  Health Go Health

"OPERATION GOLDPILL" SECOND WAVE OF INDICTMENTS LIKELY …

WEBIn February, the FBI increased its health fraud investigations capability by about 30% by reassigning 50 agents to that area. Biden's bill, S 2652, would roughly …

Category:  Health Go Health

COVID-19 Developing Drugs and Biological Products

WEB25 This guidance is intended to remain in effect for the duration of the public health emergency 26 related to COVID-19 declared by the Department of Health and Human …

Category:  Health Go Health

In Brief: Council on Family Health :: Pink Sheet

WEBCouncil on Family Health: Elects three new members to its board: Bristol-Myers' Stephen Bear, Ciba's Elizabeth Culligan and Bayer's Gary Balkema. Arthur Hull …

Category:  Health Go Health

STERLING HEALTH OTC BUSINESS IN EUROPE COMBINES SANOFI …

WEBThe proposed strategic alliance of Sterling Drug and Sanofi will merge the two companies' OTC businesses in Europe on a country-by-country basis under Sterling …

Category:  Health Go Health

WARNER-WELLCOME CONSUMER HEALTH PRODUCTS' $ 1.6 BIL.

WEBWARNER-WELLCOME CONSUMER HEALTH PRODUCTS' $ 1.6 BIL. WORLDWIDE BUSINESS melds all current and future over-the-counter products of …

Category:  Health Go Health

A NEW FRONTIER IN DIGITAL HEALTH CARE: Software As …

WEBincreasingly interconnected health care environment geared to patient-centricity, cost-efficiency and appropriate self-management of diseases. This wave of innovation has …

Category:  Health Go Health

Health Canada develops IVD classification keyword index

WEBHealth Canada has developed a draft keyword index to help manufacturers of in vitro diagnostic devices classify their products into the appropriate risk class1,2. …

Category:  Health Go Health

European Medicines Agency Guidance for Applicants seeking …

WEBIs it possible to involve World Health Organisation (WHO) experts in scientific advice? 23 Instructions for users To obtain information on a certain topic, simply click on the …

Category:  Health Go Health

r e g u la to r y a ctiv itie s in n o n -e C TD Gui da n ce do cu …

WEBhealth care professionals on how to comply with governing statutes and. regulations. Guidance documents also provide assistance to staff on how Health Canada mandates …

Category:  Health Go Health

European Health Data Space Talks Falter Over Opt-Out Issue

WEBCouncil Of EU Develops European Health Data Space Mandate To Kick Off Trilogue Negotiations. The Council of the EU has issued a mandate that addresses …

Category:  Health Go Health

Points to consider on the different approaches – including H …

WEBWorking document QAS/20.849 May 2020 1 2 DRAFT WORKING DO UMENT FOR OMMENTS: 3 4 Points to consider on the different approaches – 5 including H EL – to …

Category:  Health Go Health

Ex-RICH-VICKS PRESIDENT BERGMAN TO HEAD COUNCIL ON …

WEBThe Council on Family Health sponsors educational efforts on the appropriate use of medications. Among its recent efforts are a video news release "distributed via …

Category:  Health Go Health

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