Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement. Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on […]

RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement. Source: Alamy.com The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy […]

Pharmacist in deadly meningitis outbreak heading to trial

After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again. A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible may help, he says. “I believe as surely as I’m talking to you right now […]

CURE Pharmaceutical Launches New Academic Partnership Program Providing the Company’s Proprietary CureFilm™ for More Humane and Effective Animal Research

OXNARD, Calif., Sept. 06, 2017 (GLOBE NEWSWIRE) — CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology company, today announced the launch of a new academic partnership program, CureDotsTM. Under the CureDotsTMprogram, academic institutions may access the Company’s patented, multilayer oral thin film (OTF), CureFilm Oral™, for more humane and effective animal research and testing. CureDotsTM are punch-hole […]

US pharmaceutical company expands Dublin presence

PTC Therapeutics, a US pharmaceutical company, plans to expand its European headquarters in Dublin to 40 staff. The Dublin site of the company is responsible for finance, quality assurance, legal and a raft of other back office roles. “We currently employ 30 people in the Dublin office and this will increase to a total of 40 […]

Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD. The Design History File The […]