FiercePharma, Thursday, February 15: “Pharma unleashes lobbying power to fight surprising—and costly—changes to Medicare Part D Pharma only recently suffered in Congress’ shutdown-averting spending deal, which put the industry on the hook for bigger discounts in the Medicare Part D coverage gap, but its advocates in Washington are acting fast to try to reverse the…
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February 2, 2018: PDG® is a global pharmaceutical consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. As such, PDG is an integral part of client decision-making processes with regard to the designation of FDA U.S. Agents and Official Contacts. In addition,…
DetailsJanuary 12, 2018, Juliette Preston reports in MedCity News “…here’s a round-up of prescription drugs set to expire in 2018 — based on current information… The list began with the National Pharmaceutical Services (NPS) calendar of medications coming off-patent by 2022. This was cross-referenced with the FDA’s ‘Orange Book,’ which provides up-to-date information on the…
DetailsAs a pharmaceutical industry professional, you already know there are a bevy of different types and structures of clinical studies. However, you may need a resource to help you sort them all out. This paper includes a variety of categorical descriptions of types of studies, controls, designs, definitions and examples, including links to authoritative source material.…
DetailsAccording to CDER “Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. Certain…
DetailsJanuary 18, 2018, John Nosta reports in Forbes that “Today, Intermountain Healthcare announced a bold initiative to establish a not-for-profit generic drug company aimed at ending shortages and reducing prices. Intermountain Healthcare is leading a collaboration with Ascension, SSM Health, and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form the…
DetailsJanuary 3, 2018, Zachary Brennan reports in RAPS Regulatory Focus that “Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the…
DetailsJanuary 10, 2018 FDAnews reports “OPDP Enforcement Letters in 2017 Hit Record Low… The FDA’s Office of Prescription Drug Promotion issued just three warning letters and one untitled letter in calendar year 2017 — a record low and down from a high of 156 in 1998.” Previously, on January 3, 2018 Michael Mezher reported in…
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In January 2018 this introduction to clinical trials was prepared by the pharmaceutical consultants at PDG who routinely design and write clinical trial protocols. This paper represents a collection of quotes and resources ranging from basic primers to more advanced concepts. This is provided for drug and medical device professionals who may not serve in…
Details(Reuters) – “The U.S. Food and Drug Administration is aiming to approve drugs based on very early data if the drug shows a possible benefit in terms of survival, the head of the agency told lawmakers at a hearing on Thursday. Speaking before the House Committee on Energy and Commerce, FDA Commissioner Scott Gottlieb said…
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