{"product_id":"the-pharmaceutical-regulatory-process-9781138381285","title":"The Pharmaceutical Regulatory Process","description":"\u003cp\u003e • Author(s): Ira R. Berry\u003cbr\u003e • Publisher: MIXPBS\u003cbr\u003e • Publisher Imprint: MIXPBS\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.\u003c\/p\u003e\u003cp\u003eNew chapters cover: \u003c\/p\u003e\u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003ethe marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance\u003c\/li\u003e \u003cli\u003epharmacovigilance programs designed to prevent widespread safety issues\u003c\/li\u003e \u003cli\u003elegal issues surrounding the sourcing of foreign APIs\u003c\/li\u003e \u003cli\u003ethe issues of counterfeit drugs\u003c\/li\u003e \u003cli\u003eupdates on quality standards\u003c\/li\u003e \u003c\/ul\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Paperback","offer_id":45239571284119,"sku":"9781138381285","price":5598.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781138381285.webp?v=1769222958","url":"https:\/\/atlanticbooks.com\/products\/the-pharmaceutical-regulatory-process-9781138381285","provider":"Atlantic Books","version":"1.0","type":"link"}