Drugs
A citizen petition from two groups and three individuals is asking FDA to ban music in direct-to-consumer (DTC) television, radio and internet streamed advertisements because it distracts the audience’s attention from product side effects and contraindications. Filed by Knowledge Ecology International, the Center for Digital Democracy, and
FDA Policy/General
Mallinckrodt has agreed to acquire InfaCare, a privately held specialty pharmaceutical company focused on developing proprietary pharmaceuticals for neonatal and pediatric patient populations. The transaction includes InfaCare’s developmental product stannsoporfin, a heme oxygenase inhibitor, for reducing the production of bilirubin, the elevation of which can contribute to serious consequences
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the “automated commercial environment” or any other electronic data interchange system authorized by U.S. Customs and Border Protection
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets, indicated for relieving pain. The basis for the withdrawal is that Watson has repeatedly failed to submit the required bioequivalence data necessary to demonstrate the bioequivalence of its drug product. To view
FDA Policy/General
Federal Register notice: FDA is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for use in drug compounding, and it identifies four bulk drug substances that FDA has considered and proposes to include on its list: diphenylcyclopropenone, glycolic acid, squaric acid
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The document describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for unit-dose repackaged solid oral dosage form
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format.” The document provides clarification and additional information on recommendations to applicants submitting NDAs, BLAs, and efficacy supplements to approved NDAs or BLAs. To
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — Time and Extent Applications for Nonprescription Drug Products (21 CFR 330.14)” (OMB Control Number 0910–0688)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document describes FDA’s current recommendations about endotoxin limits and discusses a risk-based approach of weighing the potential risks of not evaluating endotoxin levels in
FDA Policy/General
Federal Register notice: FDA has issued a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on “Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.” The document provides FDA’s regulatory approach for device products with multiple functions including at least one device function and includes such device
FDA Policy/General
Federal Register notice: FDA is announcing a 9/8-9 virtual meeting of its Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. On 9/8, panel members are scheduled to discuss and make recommendations on the classification of facet screws systems, which are currently unclassified pre-amendment
FDA Policy/General
The U.S. House of Representatives has passed an FDA spending bill that sets the agency’s 2021 discretionary funding at $3.212 billion, an increase of $40.8 million (less than 1% increase) above the 2020 enacted level. Total funding for the agency, which includes user fees, is $5.
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of Hikma International Pharmaceuticals’ abbreviated new animal drug application for 1-gram bolus of phenylbutazone in horses because the product is no longer manufactured or marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications made during January, February and March. FDA is making available summaries of the basis of approval and environmental review documents, where applicable. To view
Drugs
Indivior Solutions has pleaded guilty to one felony count and agreed to pay a total of $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment Suboxone (buprenorphine). An earlier $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group, and
FDA Policy/General
Federal Register notice: FDA has issued a 10-year debarment order against Jin Su Park from importing or offering for import any drug into the U.S. The action is based on Park being convicted of one felony count under federal law for importing misbranded drugs. To view the notice,
FDA Policy/General
Federal Register notice: FDA has issued a debarment order permanently debarring Euton M. Laing from providing services in any capacity to a person that has an approved or pending drug product application. The action is based on Laing’s 8/2019 conviction for criminal conspiracy against the regulation of a
FDA Policy/General
Federal Register notice: FDA has issued a 10-year debarment order against John Seil from importing or offering for import any drug into the U.S. The action is based on 2019 felony convictions for distributing male sexual enhancement pills that he marketed as herbal remedies but that contained undisclosed
FDA Policy/General
An investor consortium led by AGIC Capital has agreed to acquire U.S. pharmaceutical firm Ritedose Corp. from private equity firm Olympus Partners. The transaction will help AGIC to expand its customer base and identify business opportunities in China, and the rest of Asia. Ritedose is headquarted in Columbia, SC
FDA Policy/General
Federal Register notice: FDA is proposing to establish requirements for the deadline and annual summary contents for sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient under the Right to Try Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies — 21 CFR part 58” (OMB Control Number 0910-0119). To view the notice, click here.