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Drugs provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 2 Aug 2021), Cerner Multum™ (updated 3 Aug 2021), ASHP (updated 30 July 2021
· THE DRUGS AND COSMETICS ACT AND RULES THE DRUGS AND COSMETICS ACT, 1940 as amended by the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960, Protection of action taken in good faith. 38. Rules to be laid before Parliament. THE FIRST SCHEDULE THE SECOND SCHEDULE . 8 THE DRUGS AND COSMETICS ACT, 1940
· Canada's regulatory approach. Drugs for rare diseases are authorized for sale in Canada under the Food and Drugs Act and Part C of the Food and Drug Regulations.. For more information on approved products, refer to Drug and medical device highlights. On this page
Orphan drugs would be given a price equivalent to 100% of the weighted average price of alternative treatments. Pacific Bridge Medical’s regulatory experts will take all factors into account and help your pharmaceutical or biotechnology company determine the most cost-effective and time-efficient way to obtain product approval in Korea.
· Innovative 3-in-1 Protection. Bullet List. Kills fleas, ticks, and chewing lice. Repels mosquitoes, ticks, and stable flies. Protects for a full 30 days. Single Paragraph.
The CODAN Chemoprotect ® product range offers a safe and reliable protection of medical personnel during the handling of cytotoxic drugs. The combined use of specially matched individual products considerably minimises the risk of contaminations in the regular handling of cytotoxic drugs as well as in case of accidents.
· The hefty price tag, sweeping label and potential popularity of Biogen's newly approved Alzheimer's disease drug Aduhelm could create a heavy burden on the Medicare system and lead to drug price
The drug company must follow the ASEAN common technical documents (ACTD) to be certified as compliant. While seemingly straightforward, the drug approval process is still not consistent across all ASEAN countries. For example, only about 5% of the drug industry in the Philippines is
Drugs provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 2 Aug 2021), Cerner Multum™ (updated 3 Aug 2021), ASHP (updated 30 July 2021
Federal Institute for Drugs and Medical Devices. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. At the BfArM , roughly 1,000 employees are involved in licensing, improving the
· •Generics QbR Deficiencies • Container closure attributes to ensure product quality • Studies to identify necessary attributes including identity, suitability (safety,protection, compatibility, and performance) consistent with the QTPP • Dosage form compatibility (e.g. extractables, leachables, dye from labeling) • Compatibility with the sterilization procedure
DEHNbox TC B 180. The compact surge arrester provides reliable protection for information technology interfaces, especially telecommunications connections such as VVDSL and G.fast (up to 1 G.Bit/s) with interference-free data transmission. Red/LineSurge protection
Patent protection and the market exclusivity that comes with it help to ensure a return on investment. A patent holder has the right to exclude others from making, using, and selling the patented invention for a defined period. Therefore, patented drugs are temporarily safe from the competition of generics, often resulting in substantial revenues.
Patent protection. Without adequate and effective patent protection, the research-based pharmaceutical industry would not exist. Fortunately, the standards for protection of intellectual property in the United States, Europe, and Japan are, for the most part, adequate.
· No Prescription For Consumer Protection. Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very appetizing. FDA regulated manufacturers of prescription medical products
· A Q&A guide to pharma & medical device regulation in South Korea, covering the healthcare bodies and competent authorities, marketing authorisation, defective and
· Russia presents a potentially lucrative market for medical device companies. However, the registration process can be a challenge. Unlike most countries, Russia still relies on in-country testing and clinical data to approve medical devices, even if the device is already sold in other major markets.
· Approval of medical devices in both the EU and the United States share some similarities ().The FDA assigns devices to 3 main regulatory classes low risk or Class I, moderate risk or Class II, and high risk or Class III ().In the United States, a Class I device requires merely a Premarket Notification without clinical trials, whereas Class III devices require clinical trials and/or other
· The exclusion for drug and medical equipment manufacturers may not be permanent. The HHS wants to study the issue and figure out which types of devices, drugs, or companies should get an exemption. The device industry officials say they expect to get some type of safe harbor in the final rule.
· Prices of innovative drugs are mainly negotiated. 4. The law reforming the pharmaceutical market (Arzneimittelmarkt-NeuordnungsgesetzAMNOG), which took effect in January 2011, has kept the principle of free pricing at launch but imposes a systematic and formal assessment of the . 6 │
An insight into regulatory, pricing and reimbursement in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook South Africa, available to purchase here for USD 99.. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
· The “most important factor” that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government-protected “monopoly” rights for
· Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs. Am J Health Syst Pharm 2018 75 . Berdi F, Powell MF, Sanz C, Gonzalez R and Massoomi F. Assessing the efficiency of CSTDs for compounding.
· drug transfer device (CSTD)) Prepared intravenous or intramuscular solution (if not using a closed system drug transfer device (CSTD)) Irrigation (bladder, heated intraperitoneal chemotherapy (HIPEC), limb perfusion, etc.) Aerosol Treatment No respiratory protection splash protection if potential for patient to spit up or vomit XX
· In Japan, drugs and medical devices can be designated as orphan drugs or medical devices based on the Article 77-2(PDF 87KB) of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics if they are intended for use in less than 50 000 patients in Japan and for
· Getty Images. Russia's Sputnik V coronavirus vaccine gives around 92% protection against Covid-19, late stage trial results published in The Lancet reveal. It has also been deemed to be safe
