In the prepublication of the Federal Register (here) which will publish on May 15, 2023, the FDA announced that Makena (Hydroxyprogesterone Caproate injection) will be removed from the Orange Book (OB) along with eight (8) generic applications that referenced Makena as the RLD in its application. Makena was originally approved in 2011 under the accelerate […]
While we know there are probably thousands of unapproved drug products being marketed in the US, many of which claim to be dietary supplements which have undeclared drugs in their composition, the danger of these products cannot be understated. Just search the web for erectile disfunction products, weigh loss products, products claiming to prevent, cure […]
Based on the longstanding knowledge that diethylene glycol (DEG) and ethylene glycol (EG) are dangerous at levels that may exceed USP‑NF limits and because of the recent misadventures and deaths resulting from these incidents, the FDA has revised a 2007 guidance to provide further recommendations regarding the identification and quantification of these contaminants in drug […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
FDA has warned consumers not to use two products containing ammonia chloride, “Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy.” The Agency says, “Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction” and it “has received reports of adverse events […]
Today we address what might seem like an ongoing problem with no end. I refer to the submission of unsolicited amendments by DMF holders during an ANDA review cycle. If the DMF holder is unaware of the status of an ANDA and they do submit an unsolicited amendment, it could delay the review cycle or […]
The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions. If you have been following the debarment notifications […]
On Monday, the FDA announced a change to the REMS for opioids to include a requirement “to make prepaid mail‑back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.” As part of the new, revised REMS requirement, “all manufacturers of opioid analgesics used in outpatient settings are […]
The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]
The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]
