FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Format and Content Requirements for Over-the-Counter Drug Product Labeling — 21 CFR Part 201” (OMB Control Number 0910-0340). The collection supports FDA regulations that establish standardized content and format requirements for OTC drug product labeling,
Drugs
Start-up pharmacy Valisure (New Haven, CT) has made a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for consumers. The pharmacy's laboratory analysis is behind the ongoing recall of ranitidine, (see earlier story) and it has detected dozens of other quality
Drugs
Regenxbio has filed a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases. The complaint alleges that FDA’s final agency action is “contrary to law and arbitrary and capricious because it did not follow the statute or its own regulations,
Devices
FDA has granted AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy images for potential diagnosis of gastric cancer. The company says its system “applies neural network algorithms which are trained with large real-world datasets of images of biopsy-proven cancer lesions, benign
Drugs
FDA has granted Allergan a Qualified Infectious Disease Product designation and fast track status for ATM-AVI (aztreonam and avibactam) for treating complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. ATM-AVI has shown activity against metallo beta-lactamase-producing Gram-
Drugs
FDA Withdraws Haemonetics ANDA Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags. 11/08/2019 Info Collection on Generic Drug Correspondence Federal Register notice: FDA submits to OMB an information collection revision entitled for “Controlled Correspondence Related to Generic
FDA Policy/General
AMPAC Fine Chemicals has acquired UniTao Pharmaceuticals’ active pharmaceutical ingredient manufacturing facility in Petersburg, VA. The facility includes four plants with multiple cGMP manufacturing lines totaling more than 80,000 gallons of cGMP capacity. It has a long history of producing Schedule II controlled substances, and its capabilities include high
Drugs
Aurobindo is recalling 38 lots of over-the-counter ranitidine tablets (150 mg), Rx ranitidine capsules (150 mg and 300 mg), and ranitidine syrup (15mg/mL). An FDA notice says the medications contain unacceptable levels of N-nitrosodimethylamine (NDMA). The notice says FDA has advised companies to recall their ranitidine
Drugs
FDA has approved Celgene’s Reblozyl (luspatercept-aamt), the first therapy to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. An agency notice says that beta thalassemia (Cooley’s anemia) is an inherited blood disorder that reduces the production of hemoglobin. In people
Drugs
FDA has accepted for review a Cassiopea NDA for clascoterone cream 1% for treating acne. The agency has set a user fee review action target of 8/27. Clascoterone is a new chemical entity and first-in-class topical androgen receptor inhibitor, which is also under development for treating under
FDA Policy/General
President Donald Trump told reporters at the White House 11/8 that the administration’s new rules on e-cigarettes should be out within a week. An element in the plan will involve raising from 18 to 21 the legal age for purchasing vaping products, he said. The Hill reports
Devices
Teleflex has begun a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, because the device’s vented gas is below the stated pressure. A company communication to customers instructs them to quarantine affected products, according to a recall
Devices
A New York federal judge has approved a settlement between the Justice Department and Life Spine Inc., and two of its executives, resolving a whistleblower’s allegations that they paid millions of dollars in kickbacks to surgeons to induce them to use the company’s spinal implants, devices, and equipment.
Devices
CDRH Office of Product Evaluation and Quality regulatory advisor Joshua Silverstein says FDA revised a 9/28/18 draft guidance on a proposed new Special 510(k) policy in response to comments received on it. Speaking during a CDRH Webinar on the finalized guidance that was issued 9/13, Silverstein
Drugs
AbbVie has submitted a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of patients 70 years old or younger with chronic lymphocytic leukemia or small lymphocytic lymphoma. The submission is based on data from the Phase 3 E1912 study, which was sponsored by the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags because the company notified the agency that the drug is no longer being marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled for “Controlled Correspondence Related to Generic Drug Development OMB Control No. 0910-0797." The revision responds to goals negotiated under the generic drug user fee program, which commits the agency to responding to questions submitted as
Drugs
Responding to a 4/5 Braeburn petition, FDA says it is revoking, as improperly granted, Indivior’s orphan drug designation for Sublocade (buprenorphine) for treating opiate addiction in opiate users. The agency’s response to Braeburn says the orphan drug designation was predicated on a demonstration that there was “no
Drugs
FDA says it has approved changes to the labeling for Bristol-Myers Squibb’s Baraclude (entecavir) tablet and oral solution to include data from a post-marketing study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients
Drugs
FDA has granted EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies (DLB). The company is planning a Phase 2 proof-of-concept study (AscenD-LB) of neflamapimod in mild-to-moderate DLB. The primary objective is to determine whether neflamapimod can improve
FDA Policy/General
Federal Register notice: FDA is seeking comments on a draft document that details best practices for drug safety surveillance entitled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” The document discusses risk-based principles that support ongoing FDA postmarketing safety surveillance for drug and biological
Drugs
Sen. Gary Peters (D-MI) says he is investigating the rising costs of prescription drugs and the short supply of critical medications affecting hospitals and patients. According to Peters’ statement, unaffordable prescription and hospital-administered drugs and the increasing number and length of drug shortages “have become an economic, national