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Hyman, Phelps & McNamara, P.C. Document Search Results (257) Show: results per page Sort by:  | FDA’s High Risk Pharmacy Inspections and Enforcement Actions: Coming to a Sterile Compounding Pharmacy Near You?
Jeffrey N. Gibbs, Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 14, 2013 On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its surveillance and enforcement approach...
| | D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 11, 2013, previously published on April 9, 2013 As food and drug attorneys, we rely on a certain level of FDA transparency to understand why FDA did what it did in a particular case, and to discern what that means for future Agency action (or inaction) in another case. One way we get the transparency we need is by submitting Freedom of...
| | Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
Kurt R. Karst, Etan J. Yeshua; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 11, 2013, previously published on April 7, 2013 Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions. In doing so, Judge Edward R. Korman of the U.S. District Court for the Eastern...
| | Food Traceability: Recordkeeping Without Regard to Risk?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 11, 2013, previously published on April 9, 2013 Section 204 of the Food Safety Modernization Act ("FSMA") directed FDA to establish pilot projects “to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious...
| | Are Your “Natural” Food and Supplement Ingredients Really Natural? The National Organic Program Issues Draft Guidance Concerning Definition of Natural vs. Synthetic
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 6, 2013, previously published on April 5, 2013 Under the Organic Food Production Act (“OFPA”), the National Organic Program (“NOP”) of the USDA is authorized to establish the National List of Allowed and Prohibited Substances (“National List”). This National List contains each synthetic substance that is...
| | DEA Endorses Citizen Petition To Limit Approved Uses and Impose Maximum Day and Quantity Limits on Controlled Release Oxycodone-Hydrochloride
Delia A. Stubbs; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 4, 2013, previously published on April 3, 2013 As previously reported, Congress recently introduced the Stop Oxy Abuse Act that would restrict the labeled indications for use of any controlled release drug containing Oxycodone-Hydrochloride (HCl) to “severe-only” versus current labeling of “moderate-to- severe” pain. The...
| | FSMA Preventive Controls and OMB: No Cloak or Dagger
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 3, 2013, previously published on April 2, 2013 When FDA published its proposed rule on preventive controls as authorized by FSMA, we noted that FDA requested comment on a number of important issues that were not addressed in the text of the regulation itself, namely product testing, environmental monitoring, and supplier approval and...
| | Discord Among Accord and Acorda Over AMPYRA Biostudy Sample Leads to Restricted Distribution Antitrust Lawsuit
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 3, 2013, previously published on April 2, 2013 A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D....
| | Administrative Law Trumps the “Immutable Laws of Science,” Says the DC Circuit in Challenge Over Generic Derma-Smoothe Approvals; Hill Appeals and Denial Quickly Follows
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 2, 2013, previously published on March 28, 2013 A recent per curiam decision from the U.S. Court of Appeals for the District of Columbia Circuit may be the last word in litigation Hill Dermaceuticals, Inc. (“Hill”) initiated in November 2011 against FDA, as Hill filed a petition for rehearing last week that was denied earlier this...
| | Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 2, 2013, previously published on March 31, 2013 Depite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter. If a company - or FDA - misses a deadline by just one day, then opportunities provided by the statute can be...
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