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CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care
…tendonitis and bursitis; pain related to minor surgeries with minimal tissue injury, and mild postoperative pain; dental pain, kidney stones, and headaches including migraines. Opioid therapy plays an important role…
Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?
…of procedural informed consent a surgeon ordinarily would present to a patient. The introductory paragraph states: The review and understanding of this document is a critical step in making the…
Days Go By* – Particularly When Responding to an FDA Inspection
…listed on the FDA investigator’s report (a Form 483). When an establishment receives a Form 483, FDA’s Compliance Program Manual for Inspection of Medical Device Manufacturers indicates that “Corrections and…
FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests
…submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive PDF template that: allows for form construction and autofill, complements internal review templates used…
CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes
…an “all-in” definition of “manufacturer,” which would have required that a manufacturer and all of its affiliates, subsidiaries, business segments, and entities under common corporate ownership or control each maintain…
Final Medicaid Best Price Changes Encourage Value Based Purchasing but Discourage Copay Assistance
…to encourage value based arrangements in Medicaid New regulations to implement the alternative rebate for line extensions, including definitions of “new formulation” and “oral dosage form” A new, difficult hurdle…
CIPRO Patent Settlement Case is Appealed to the California Court of Appeal
…flawed and highly criticized line of federal authority: Instead of applying the per se rule or the rule of reason under California law, the Superior Court adopted a rule unprecedented…
CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements
…products. Several states have passed legislation allowing the use of CBD in foods and supplements, but many other states have declared such uses illegal. Although FDA maintains its position that…
Seeking Clarity, Cigar Importer Sues FDA
…relating to flavored cigarettes. FDCA section 907(a)(1) bans cigarettes that contain a “characterizing flavor” as of September 22, 2009. FDA issued a Letter to Industry on the eve of the…
FDA’s Holding-on-the-Merits Standard – Will it Apply Post-MMA?
…triggering purposes. Several years later, in Teva Pharm., USA, Inc. v. FDA, 398 F. Supp. 2d 176 (D.D.C. 2005), Teva challenged an FDA decision that a dismissal of a declaratory…
Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the Internet
…a relationship. The Act requires an “in-person medical evaluation.” Is “an in-person medical evaluation” the same as a “physical examination?” We surmise that an “in-person medical evaluation” appears close to…
Are There Only Two Types of Tests in Clinical Studies – Legally Marketed or Investigational? Maybe, according to FDA’s Draft Guidance for Investigational IVDs
…of the investigational therapeutic product” (emphasis added). The guidance also provides several examples of IVD uses that it considers to be investigational: Identifying subjects for study enrollment criteria (e.g., inclusion,…
Don’t Test Me! FDA Applies “Deemed Triggered” Regulation to 180-Day Generic Drug Exclusivity
…first glance, the different PC expiration dates don’t seem terribly out of order. After all, there are many instances of staggered 180-day exclusivity expiration dates based on different commercial marketing…
FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
…510(k) submissions for those devices.” General Considerations: What Makes Implants Unique Compared to Other Device Types? Implant devices are unique because they are designed for continuous implantation for a period…
Criminal Convictions for Compounding Activities Overturned for “Legal Impossibility”
…verdict for conspiring to defraud the United States, also known as a Kleinconspiracy. The core allegation was that the defendants were engaged in a concerted effort to hold out NECC…