Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Emmett F. Branigan Bellingham, WA (5/7): FDA inspected the physician’s office 1/29-31 and documented significant GMP deviations involving human cells, tissues, and cellular and tissue-
Drugs
FDA has issued a draft guidance, Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations, with recommendations for conducting in vivo absorption trials for the subject ingredients. The document says a maximal usage trial (MUsT) is a standard
Drugs
The U.S. House of Representatives has passed S. 204, the Senate version of the Right to Try Act that was passed by that chamber 8/2017. Health advocacy group Public Citizen says that the “Senate’s seriously flawed False Hope legislation, opens the gate to a dangerous, uncharted pathway
Drugs
FDA commissioner Scott Gottlieb says the agency will follow its 11/2017 regenerative medicine advanced therapy designation guidance with a similar framework explaining how FDA will address manufacturing issues and the development pathway for gene therapy products. In a 5/22 presentation to the Alliance for Regenerative Medicine annual board
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the inclusion of a model-informed drug development (MIDD) program in PDUFA 6, but sees areas of MIDD pilot that need additional clarification. The association’s comment letter identifies the areas as the goal, format, eligibility criteria, and selection process.
Drugs
MBI Distributing has recalled all lots of its homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir. The drug products have been found to be manufactured with a lack of adequate controls, according to a recall notice. “Manufacturing products
Drugs
FDA has made available a guidance on “Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.” The document provides recommendations for establishing clinical effectiveness based on FDA’s assessment of issues raised in the review of clinical trials for such products. The agency says it does does not address systemic
Drugs
FDA has posted a guidance entitled “Bioanalytical Method Validation” that discusses validating bioanalytical methods used in human clinical pharmacology, bioavailability, and bioequivalence studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation. The document can also inform the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker
Drugs
FDA has approved an AkaRx NDA for Doptelet (avatrombopag) tablets to treat low blood platelet count in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. In clinical trials, Doptelet was demonstrated to safely increase platelet count, an agency release says. It adds that
Drugs
FDA has released a three-page Form 483 sent to Auronext Pharma following a March inspection of the firm’s Bhjwadi, India manufacturing facility. Agency investigators said the firm has unsubstantiated ranges for a critical process parameter for its vial sealing machine. FDA also said employees lacked the training to
Drugs
FDA has accepted for review a Cosmo Pharmaceuticals NDA for Aemcolo (rifamycin SV MMX) for treating patients with travelers’ diarrhea. The agency has set a user fee review action target date of 11/16. “Resistance to currently available antibiotics is a serious issue and there have been no new chemical
Drugs
FDA has posted a guidance on “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.” The document provides recommendations for establishing clinical effectiveness for such drugs that do not cause structural disorders of the hypothalamus or pituitary gland. The drugs should both increase serum testosterone
Drugs
FDA has approved an Amgen BLA for Aimovig (erenumab), a once-monthly self-injection for preventing migraines in adults. Aimovig is the first monoclonal antibody targeting the calcitonin gene-related peptide receptor approved for migraines, an agency release says. Approval is based on data from three clinical trials. Overall, patients
Drugs
FDA has published a draft guidance on “Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.” The document provides recommendations for developing such drugs for treating patients who have undergone solid organ or hematopoietic stem cell transplantation. It addresses FDA’s current thinking on the overall development program and
Drugs
FDA has issued a safety alert about decreased survival associated with the use of Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the
Drugs
FDA has issued a safety alert about serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Viiv Healthcare’s Tivicay) used to treat human immunodeficiency virus. “Preliminary results from an ongoing observational study in
Drugs
FDA and HHS’ Office for Human Research Protections have issued a joint guidance on “Institutional Review Board (IRB) Written Procedures; Guidance for Institutions and IRBs.” The document is intended to clarify requirements, reaffirm important human subject protections, and provide consistent recommendations for institutions and IRBs reviewing and overseeing research involving
Drugs
Three Alston Bird patent lawyers say a Federal Circuit Court of Appeals decision in Lilly v. Actavis Elizabeth conflicts with Supreme Court precedent and should be overturned. Writing in the New York Law Journal, the attorneys say the appeals court held that substantial non-infringing off-label uses of an
Drugs
FDA has released the names of 52 branded drug products whose manufacturers “have potentially been blocking access to the samples of their branded products” needed by generic drug companies to be able to develop and test their products. In a statement, FDA commissioner Scott Gottlieb said the agency hopes “that
Drugs
Vermont has become the first state to approve legislation permitting a U.S. drug wholesaler to import drugs from a Canadian wholesaler. The law still has to be certified by HHS. The Trump administration has opposed such drug importation. The Hill reports that HHS secretary Alex Azar called the idea
Drugs
FDA reportedly has backed away from awarding a sole source contract to the Duke-Margolis Center for Health Policy headed by former agency commissioner Mark McClellan, for whom now commissioner Scott Gottlieb used to work. Endpoint News says an initial request for proposal said the effort was to “provide supporting
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for a generic version of Daiichi Sankyo’s Welchol (colesevelam HCI) tablets, 625 mg. The product is approved along with diet and exercise for lowering LDL or “bad” cholesterol. It can be taken alone or with other statin cholesterol-lowering drugs. Welchol had