product

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product

in PRODUCT LIABILITY, any goods or electricity including any goods comprised in another product whether by virtue of being a component part or raw material or otherwise. ‘Goods’ is defined as including substances, growing crops and things comprised in land by virtue of being attached to it, and any ship, aircraft or vehicle.

References in periodicals archive ?

The agency has called on concerned establishment not to distribute the said drug products "until these have already been covered by the appropriate authorization."

FDA warns public anew against six unregistered drug products

However, as Brazilian drug producers are still responsible for 74% of all refused processes and no Brazilian drug product was approved to American or European market on 2015, it can be concluded that they are still not able to follow Brazilian regulation or foreign ones [12, 27].

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

The process of integrating these 23 US generic drug products is well underway with the successful manufacture of engineering batches of 1mg and 8mg Doxazosin Mesylate tablets in IDT's Boronia manufacturing facility.

FDA CONFIRMS CHANGE OF OWNERSHIP OF GENERIC DRUGS

Pairing the fill-finish equipment and parenteral packaging components is critical to ensure drug product manufacturing runs efficiently.

Elastomeric closures in parenteral drug packaging: steam vs. gamma sterilization

Critical quality attributes (CQAs), determined with the patient in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product's lifecycle.

West expands NovaPure line

For example, leachables and extractables play an important role when looking at primary packaging material, storage and manufacturing of drug substances and drug products. During manufacturing, the product or its precursors, as well as excipients get into direct contact with different materials; for example glassware, rubber and plastics.

The new health believes in having skin in the game: genotoxic impurities, leachables and extractables the tip of the iceberg? Genotoxic impurities, in particular, are at the focus of attention of the regulatory authorities. Low limits of detection in the trace range presuppose the existence of special analytical techniques for detecting these substances

"At Global Pharmatech, we are always striving for innovation in our drug products whether that is in drug manufacturing or research and development.

Global Pharmatech obtains patent purification methodologies of echinocystic acid

Lonza has entered an agreement to purchase a sterile drug product fill and finish facility from Novartis.

Lonza to Acquire Novartis' Sterile Fill/Finish Facility

"To check if a drug product has been registered with FDA, use the embedded Search feature of the FDA website accessible at www.fda.gov.ph," the agency said.

FDA warns public against six unregistered drug products

SHANGHAI, March 27, 2019 -- STA Pharmaceutical Co., Ltd., (WuXi STA)--a subsidiary of WuXi AppTec--announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA).

WuXi PharmaTech (NYSE: WX) - WuXi STA's New Drug Product Manufacturing Facility Passes First European MPA GMP Inspection -- 27/3/2019

In addition, the Company reports that it has completed production of the drug product for the ensuing GLP Safety/Toxicology studies of its lead drug candidate in the HerpeCide program.

FDA responds to NanoViricides' request for pre-IND meeting

This could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product. This would allow them to be marketed as a prescription or over-the-counter drug products with medical claims for smoking cessation or related indications ultimately reducing the likelihood of someone continuing to suffer the clinical consequences of smoking.

United States : Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes