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The Clot Thickens! Bloggers Beware! Congress Requests Information from Drug Rep. Website on Anonymous Postings Concerning Early ENHANCE Study Results
…the letter) “all records relating to any posting on Cafepharma.com related to the ENHANCE study, including but not limited to, names, addresses, phone numbers, and e-mail and internet protocol addresses…
New Proposed Rule and Draft Guidance Issued to Allow for the Importation of Prescription Drugs
…stating that the MMA product conforms to the information described in the approved application regarding the quality of drug substances, drug products, intermediates, raw materials, reagents, components, in-process materials, container…
“It’s In the Mail” Will Soon No Longer Apply to DEA Registration Applications
…in June 2020, DEA had stopped mailing renewal notifications to registrants and instead stated that it would send out electronic reminders to renew at 60, 45, 30, 15, and 5…
There’s a New Reporting Tool in Town
…complainant who, for example, submitted an unreliable or inadequately documented complaint to the Agency, CDRH now has committed to “follow-up communication” and a tracking system. This will allow submitters to…
Food Design and the 2010 Dietary Guidelines: If Food Companies Comply, Will Consumers Buy?
…Act of 2010 authorizes USDA to set nutritional standards for foods sold in schools, including vending machines, lunch lines, and school stores. Combating the problem from a different angle, Alabama’s State…
Trump Administration Takes a Turn at Medicare Part B Payment Reform
…other developed economies (Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and United Kingdom). The HHS analysis found that, on average, the…
Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation
…calls on the Department of Justice, the Federal Trade Commission, the Agriculture Department, the Treasury Department, the Department of Commerce, the Department of Health and Human Services (DHHS), and other…
Government Seeks to Dismiss Lawsuit Challenging the Canadian Drug Importation Rule
…will evaluate SIPs based on the criteria set forth in the Final Rule. Six states (Vermont, Colorado, Florida, Maine, New Mexico, and New Hampshire) have passed laws allowing for the…
Florida Proposes Plan to Import Drugs from Canada
…on behalf of the various state programs. In accordance with federal law, the Florida program will not import controlled substances, biological products, infused and parenteral drugs, intravenously injected drugs, or…
FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain
…drugs meet the conditions in the FDA-approved NDA or ANDA (including cGMP compliance). A plan to test the drugs, as required by section 804(e), including for authenticity, degradation, and to…
FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?
…of antihistamine, antitussive, bronchodilator, expectorant, nasal decongestant, and internal analgesic-antipyretic ingredients permitted under the monograph, consumers seeking relief from the symptoms of the common cold are often looking for an…
Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?
…a set of principles and criteria. The NIH, which accepted the IOM report, charged a working group with, among other things, developing a plan of action to implement the guiding…
FDA Will Meet to Address Possible Behind-The-Counter Drug Availability
…wishing to attend the meeting must register with FDA by November 5, 2007. Several other countries, including Australia, Canada, France, New Zealand, United Kingdom, Denmark, Germany, Italy, Netherlands, Sweden, and…
DDMAC Digs Deep to Link Unbranded Websites to Violative Promotional Practices
…recommended that physicians test their patients for “suboptimal” plasma levels through Avantix Laboratories. To add insult to injury, DDMAC determined that the Avantix website, www.bloodleveltesting.com, was registered to Novartis, its…
What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?
…as “consistent with applicable law,” which, again, requires a certification under 804(l) for 804(j) to be in effect. While then-Secretary of Health and Human Services, Alex Azar, made a certification…