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Royal Flush? Trade Groups Challenge a Second Drug Stewardship Program; This Time the Target is King County, Washington
…Disposal Ordinance. Both measures require brand-name and generic drug manufacturers to shoulder the financial burden of local take-back obligations, including collection, transportation, disposal, public outreach, and administrative expenses. But the…
South Korea Aims to Establish Biohealth Industry as Strategic Sector, Following Success in Semiconductor and Biopharmaceutical Production
…medical devices; Innovative and essential pharmaceuticals; Digital health care; Advanced regenerative medicine and advanced bio-pharmaceuticals; DNA tests; Brain-machine interface; Infrastructure” We are excited to hear that South Korea is investing…
New REMS for Prescription Oral Sodium Phosphate Products Raises Questions on Application of REMS To Active Ingredients Available Both As Prescription and OTC
…cardiovascular and rheumatologic indications. The professional labeling allows the maker of an aspirin product to detail the professional labeling to health care providers. Prilosec OTC (omeprazole magnesium) is marketed with…
Administration Releases Two Healthcare Reform Implementation Guidances Affecting Drug Manufacturers
…generic copay. The Draft Agreement and Public Meeting: Along with the final guidance, CMS released a notice setting forth a draft model coverage gap discount agreement and announcing a public meeting…
FDA Issues Draft Guidance that Supports Developing a Risk-Based Approach to the Monitoring of Clinical Studies
…monitoring activities that can only be done in a centralized manner (e.g., statistical analyses to identify data trends); identify missing or inconsistent data and potential protocol violations; verify source data…
Pathway to Global Product Safety and Quality – FDA’s Report Regarding Improving the Quality of Imports
…approach towards these imports from port to port. Commissioner Hamburg’s prepared remarks for the Center for Strategic and International Studies in February 2010, address almost the identical issues contained in…
What is Special about September 24, 2023 for the UDI System?
The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Such codes need…
DDMAC Announces Enforcement Webinar Series
…be able to respond to all questions from attendees. We note that DDMAC has issued 4 Letters between January and April 2011, down from 18 Letters issued between January and…
Rep. Waxman Presses FDA for Action on Flavored Cigars
By Ricardo Carvajal – Rep. Henry Waxman, Ranking Member of the Committee on Energy and Commerce, sent FDA Commissioner Margaret Hamburg a letter urging the agency to investigate Kretek International’s…
Effective March 28, 2011 – New Safety Reporting Requirements for Certain Drug and Biological Products
…significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or…
Food Design and the 2010 Dietary Guidelines: If Food Companies Comply, Will Consumers Buy?
…and reduce the intake of calories from solid fats and added sugars. Although the 2010 Dietary Guidelines are intended to help form federal nutrition policy and provide guidance to be…
With New Food Safety Law, Significant Burdens on Industry (and on FDA)
…a cause of under-performance at FDA, such that a coalition of consumer and professional groups and trade associations (including a number of food trade associations) joined forces in the Alliance…
With the Food Safety Modernization Act Set to Become Law, Certain Provisions Will Take Immediate Effect
By Ricardo Carvajal – Although many of the Food Safety Modernization Act’s (“FSMA’s”) major provisions have a delayed effective date (including the requirement to develop and implement a HACCP plan), some…
Power to the Patient with Patient Generated Health Data
…PGHD can be used as part of patient care as well as in clinical trials. In clinical trials, PGHD can be used in clinical outcome assessments (COAs) that describe how…
FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
…health care and related uses. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices. Overall, the final guidance provides many editorial clarifications as…