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FDA Proposes to Update the Food Facility Registration Rules
…such as roadside stands, farmers’ markets, Community Supported Agriculture (CSA) programs, and other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online…
FDA Issues Two New Guidance Documents on Voluntary Consensus Standards, Consolidating and Replacing Earlier Guidance
…also reflected in FDA’s online database: Recognized Consensus Standards. The Draft Guidance explains that there are two “primary situations” where FDA may decide to withdraw recognition of a standard: (1)…
Gottlieb to E-Cigarette Manufacturers: Reduce Youth Use or I Will END You
…e-cigarette retailers and manufacturers for illegally selling e-cigarette products to minors. The violations were discovered during an “undercover blitz of brick-and-mortar and online stores” conducted by FDA. In a direct…
FTC Dives into the “Natural” Fray
…shampoos, and sunscreens online with 100% or all natural claims came somewhat as a surprise. According to the consent decrees and the administrative complaint, the FTC charged that the companies…
21st Century Cures Initiative: HP&M’s Frank Sasinowski Testifies at First Congressional Hearing
…Drugs and Biologics” (Docket No. FDA-2013-D-0575). A press release is available online (here), and a video recording of the hearing will also be available online (here). Chart for Proposal #3: …
A Future Regulatory Paradigm with Potential Broader Implications
…FDA held an online interactive user session, led by Associate Director for Digital Health at CDRH, Bakul Patel, to share a program update and answer attendee questions. The session walked…
Godot Finally Arrives: At Long Last, FDA Issues Draft Guidance On Submissions For Interactive Social Media
…website an online forum that gives users the opportunity to post comments about the use of its product . . . the firm is responsible for submitting to FDA the…
Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution
…alleged that “online summaries of two studies” contributed to a message of disease treatment or prevention. FDA addressed the use of the studies as follows: [U]nder 21 CFR 101.93(g)(2)(iv)(C), a…
Consumer Agrees to FTC Order for False Testimonial in Infomercial
…disclosure of material connections, and the FTC guide Dot Com Disclosures: Information About Online Advertising. (The FTC is currently seeking comment on the latter guide to determine whether an update is…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…setting?”); (2) “Pharmacy, Consumer, and Health Care Provider Issues” (e.g., “How might various types of conditions of safe use on nonprescription drug products affect pharmacy business operations?”); and (3) “Other…
DEA Publishes Policy on Prescribers’ Legitimate Use of Agents
…an agent, including a nurse in a long term care facility (“LTCF”), to communicate controlled substances prescriptions to a pharmacy. DEA notes on background that “[w]hile the core responsibilities [of]…
TriCare TRRx Refund Final Rule: A Big Stick Disguised as a Carrot
…for Fiscal Year 2008 (“NDAA-08”). Section 703 of the NDAA-08 provides that, for any prescriptions filled on or after the date of enactment (January 28, 2008), the TriCare retail pharmacy…
Stimulating Privacy: Changes to HIPAA in the Stimulus Bill
…a third party was funding the communication. Thus, a manufacturer could without a patient authorization pay a doctor or pharmacy to send prescription refill reminders to patients as well as…
House Energy and Commerce Committee Requests that GAO Update 1995 BTC Drug Study Report
…(4) There is no clear pattern of increased or decreased access to drugs as nonprescription products where a pharmacist or pharmacy class exists. (5) While a pharmacy or pharmacist class…
Pharmakon Compliance Director Pleads Guilty to Conspiracy Charges
…conspiring to defraud the United States government by lying about failed potency tests of drugs that the pharmacy had compounded. This brings back memories to me about another Pharmakon, in…