Biologics
FDA has approved a new warning on Johnson & Johnson’s Covid-19 vaccine. According to an emergency use authorization amendment posted on the agency’s Web site, the following information was added under a new subsection entitled Guillain Barré syndrome. It reads: “Guillain Barré syndrome (a neurological disorder in
Drugs
Congress has officially weighed in on Biogen’s controversial Alzheimer’s drug approval, requesting documents from the company as part of a broad investigation into whether improper actions occurred during the approval process, whether its marketing and drug pricing are appropriate. A 7/12 joint letter from the House Energy
Drugs
In a briefing document prepared in advance of a 7/15 meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee to discuss the NDA for FibroGen’s roxadustat, the agency raises safety concerns for the committee to consider. The roxadustat proposed indication is to treat anemia due to chronic
Drugs
FDA says hand sanitizer gel produced by Guangzhou, Minghui Cosmetics Co., Guangzhou, China, which recently registered with the agency as a human drug manufacturer, was detained and refused admission at the border. A 7/6 Warning Letter says agency lab testing of a batch of the detained product found that
Drugs
CDER Office of Medical Policy health science policy analyst Heather Stone says the Office of Medical Policy Clinical Methodologies Group (ClinMeth) has made the CURE ID app more effective during the Covid-19 public health emergency. CURE ID allows healthcare providers to report new uses of existing drugs for 325
Devices
During the 4/28 MDUFA 5 user fee negotiating session, industry representatives presented their overall proposal for the MDUFA 5 package. Just-released minutes of the session say the industry first confirmed its principles for the user fee program: * supporting timely patient access to safe and effective medical devices and
Drugs
Commenting on an FDA request for information and comments on evaluating the clinical pharmacology of peptides, Merck says its experience is there are few instances in which a one-size-fits-all-type requirement for clinical pharmacology studies would be appropriate. In its response, the company says that due to
Devices
FDA has accepted the first preclinical module submitted by Invivo for its humanitarian device exemption (HDE) application for the Neuro-Spinal Scaffold implant. The company says the remaining modules cover manufacturing and clinical data. All three must be accepted before an agency final approval decision. Invivo says it is currently
Drugs
FDA says its review of Web sites and social media sites maintained by Halodine, Miami, FL, found that the company is marketing non-alcohol-based antiseptic products for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 and other conditions in people. A 7/7
Biologics
Johnson & Johnson says it is in discussions with FDA and other regulators about rare cases of Guillain-Barré syndrome which have been reported following vaccination with its Janssen Covid-19 vaccine. The discussions presumably will center around whether a Warning should be added to the product’s labeling. “The
Biologics
FDA has posted a guidance entitled Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular- or Tissue-based Products (HCT/Ps). In answers to common questions, the agency says that beginning last month it no longer intends to exercise enforcement
FDA Policy/General
Federal Register notice: FDA is correcting a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants. That notice included two ANDAs that had been previously withdrawn in an earlier notice. This notice corrects the error. To view the notice, click here.
Biologics
FDA has approved a Janssen Biotech BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Approval was based on data from the 304-
Devices
Magellan Diagnostics has recalled its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of false low results. “The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such
Devices
Avanos Medical has agreed to pay more than $22 million to resolve a criminal charge relating to the company’s fraudulent misbranding of its MicroCool surgical gowns. According to the Justice Department, Avanos falsely labeled the gowns as providing the highest level of protection against fluid and virus penetration. Additionally,
Biologics
Pfizer says it is discussing its plans this week with FDA to seek authorization for a Covid-19 vaccine booster shot (see earlier story). Meanwhile on Sunday, National Institute of Allergy and Infectious Diseases director Anthony Fauci said it was too soon for the government to recommend another shot, according
Devices
FDA has announced an 11/12 virtual public workshop on orthopedic cartilage repair products. The workshop is intended to provide manufacturers, regulatory affairs professionals, clinicians, patients and the general public a forum to share information about data and studies needed to support marketing submissions for such products. To register for
FDA Policy/General
Notice Corrected on 2 ANDA Withdrawals 7/9/2021 Federal Register notice: FDA is correcting a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants. That notice included two ANDAs that had been previously withdrawn in an earlier notice. This notice corrects the error. To view
FDA Policy/General
Federal Register notice: HHS has withdrawn a 1/21 notice entitled “Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.” It is also withdrawing associated requests for proposals issued on its Web site. The department says it is not aware that any proposals were received in response to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm), indicated for preventing migraines in adults. The regulatory review period is 3,216 days, which includes 2,882 days that occurred during the testing phase and 334 days during the
Devices
St. Jude Medical has agreed to pay $27 million to settle allegations under the False Claims Act that it knowingly sold defective heart devices to health care facilities. “The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information
Drugs
FDA and CDC have dismissed the immediate need for Covid-19 booster vaccines in the wake of a Pfizer announcement that the company intends to seek such an authorization in the coming weeks. The company says that initial data from a study demonstrate that a booster dose given six months